Event date is unknown date in 2020.Complainant part is not expected to be returned for manufacturer review/investigation.Investigation summary: the implant(s) was not returned and instead the investigation will be done based on the supplied image(s) from the attachments, an x-ray of the construct, from the attachment(s) located in notes & attachments section of the product complaint.The image(s) was reviewed and no malfunction, damage, or defect was observed on the x-ray.As the implant(s) was not returned an as received condition, dimensional inspection, material or drawing reviews are not applicable.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history: part number: 235.290.Lot number: 2639254.Manufacturing site: (b)(4).Release to warehouse date: 13.Sep.2010.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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