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Traceability · technical assessment · complaints

A complaint starts with identifying the case, not with a form

With a prosthetic component, the cause may be a manufacturing defect, shipping damage, an incorrect platform, screw, library or a mismatch within the digital workflow. The more precise the information we receive at the outset, the faster we can distinguish a commercial complaint from a technical assessment.

Service workflow · updated 8 September 2026.
IdentificationOrder + REFCompatibility is difficult to verify without the specific reference.
TraceabilityLOT / UDI / obalHelps link the case to the manufacturing batch and documentation.
Digital caseLibrary + CAD dataSpecify TECH/LITE, the software and the scan body used.
ObrazPhotographs situaceProduct, packaging, connection and the relevant clinical/laboratory context.
Initial classification

Four different situations that can look the same from the outside

A

Shipping damage

Damaged packaging, missing contents or mechanical damage to the shipment. Photograph the condition of the shipment as soon as possible after receipt.

B

Suspected product defect

Dimensions, thread, surface, mechanical integrity or another property of the specific reference. Keep the component and the batch identification.

C

Compatibility / platform

The component “will not seat”, but the cause may be a platform, indexing or implant-system mismatch. Include identification of the implant and connection.

D

Digital workflow / library

Rotation, height, a model discrepancy or CAD-interface mismatch may relate to the scan body, library, print offset or workflow version rather than a defect in the physical component.

Checklist

What to send us in the first e-mail

InformationWhy we need itExample
Order / invoiceTrace the sale, date and quantity.Order or invoice number.
REFIdentifies the specific component, series and platform.IPD/…
LOT / UDIBatch traceability and, where applicable, follow-up with the manufacturer.Photographs of the label or packaging.
PhotographsHelps distinguish a shipping, mechanical or compatibility issue.Product, packaging, connection, adjacent component.
Workflow descriptionShows whether the issue arose at the clinical, CAD or manufacturing stage.implant/MUA → scan body → software → library → interface.
Digital data, where relevantHelps assess library alignment, the model or the restoration/framework.STL/PLY, CAD screenshot, library name and variant.
If possible, do not modify the problematic component further.Additional grinding, polishing or other changes may make technical assessment of the original condition more difficult. Keep the packaging and labelling as well.
What we do after receiving the information

Technical assessment in five steps

01Traceability checkOrder, REF, LOT / UDI.
02CompatibilitySystem, platform, indexing, MUA or implant level.
03WorkflowScan body, library, interface, screw, model.
04Physical conditionPhotographs and, where appropriate, collection of the component.
05Next stepCommercial resolution, technical resolution or escalation to IPD.
Clinical safety

If there is any doubt about safe use, do not continue using the component

Patient safety takes priority over completing the case.If the issue is associated with suspected medical-device failure, unusual damage or an event that may affect the patient, stop using the affected component, retain it for traceability and contact us without undue delay. Further action depends on the nature of the case, the IFU and applicable regulatory requirements.
FAQ

What most often speeds up resolution

Do I have to send the physical component immediately?

Not always. First send identification details and photographs. Depending on the nature of the case, we will agree whether physical collection is necessary.

What if the issue looks like a defect but may be related to the CAD library?

Specify the scan body used, the TECH/LITE library, the software and a screenshot or export showing the issue. The technical assessment will distinguish a library issue from a physical defect.

I do not have the LOT, but I have the order number. Is it still worth submitting the complaint?

Yes. Send everything you have. The order and REF often allow us to trace a significant part of the history, although the LOT is very helpful.

Where can I find the general contractual rules for complaints?

On the Terms and Conditions page. This page mainly explains the practical and technical process.

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