Model Number Intermediate Surgical Splint |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 06/11/2020 |
Event Type
Injury
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Manufacturer Narrative
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After review of the patient's post operative scans, it was identified that the mandible is not in the correct planned final position and deviated to the left side.3ds performed an investigation that identified no issues with the product or process performed by 3d systems.This complaint is being reported due to a revision surgery scheduled for (b)(6) 2021.At this point, 3ds cannot confirm that our products did not cause or contribute to this planned revision surgery.
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Event Description
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It was reported that for a vsp/tmj combination case, the vsp system intermediate splint could have contributed to a deviated implant positioning for a bilateral joint revision surgery resulting in malpositioned tmj devices on the patient's left side.
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Search Alerts/Recalls
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