Product complaint # (b)(4).Event year is reported as 2021; however exact date of event is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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.
|
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient went to see the surgeon as the screws had been exposed on the lesion.As far as the patient remembered, the screw exposure took place in (b)(6) 2021.On (b)(6) 2020 the patient underwent the primary orif procedure with rapidsorb system treating maxillary fracture.The patient is scheduled to undergo a revision procedure on (b)(6).No further information is available.This complaint involves unknown number of devices.This report is for (1)2.0mm rapid resorbable oblique l-plate 6h x 4h/right-sterile.This report is 6 of 7 for (b)(4).
|
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: the investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot part # 852.264.01s , lot # 7l00885 , manufacturing site: oberdorf, release to warehouse date: jun 18, 2020, expiration date: jun 01, 2023.A manufacturing record evaluation was performed for the finished article lot 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.
|