It was reported that while placing the implant, driver got stuck inside the implant.Implant had to be removed.Tooth location 46, patient will have to return to place a new implant.After conversation with colleagues, they confirmed that sometimes can be hard to separate the components.
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Zimmer biomet complaint number (b)(4).One (1) certain¿ universal ratchet extension implant driver (long) (ire200u) was returned for investigation.Visual evaluation of the as returned product identified signs of extended use, wear on the driver.Signs of use, damage on the implant likely from the removal process.Functional testing to recreate the reported event; verified the implant engaged, retained, and disengaged with returned ratchet extension as intended.A pre-existing condition noted on the per was moderate bone density (type ii).The reported implant was located on tooth # 46 (fdi) and was used, placed and removed on the same day.The length of the driver usage is unknown.Dhr review was completed for the subject lot numbers (2022091526 & 1224776).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance's, which could have caused or contributed to the reported event, were noted as part of the dhr.Lot numbers were inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot numbers (2022091526 & 1224776) for similar events and no other complaint was identified.Review completed utilizing keywords: does not disengage/release.Based on the available information, and functional testing device malfunction did not occur, and the reported event was unconfirmed.
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