An event regarding a packaging issue involving a restoration shell was reported.The event was confirmed following visual inspection of the returned part.Method & results: device evaluation and results: visual inspection was performed and it was identified that there was damage caused to the blister walls and the implant.Material analysis, functional and dimensional inspections were not completed as these aspects are not in question.Material analysis, functional and dimensional inspections were not completed as these aspects are not in question.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: nc was raised on (b)(6) 2019 to evaluate the root cause, which indicates that due to misplacement of the implant from the post, the implant is free to move around in the blister.This causes the rough surface of the implant to abrade the petg blister walls causing debris.The hazard related to this packaging issue results in the implant disassociating from its post within the packaging prior to surgery, ultimately leading to the patient being exposed to excessive coating debris/unintended foreign object (petg and tpu packaging particulates).
|