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.Complainant part is not expected to be returned for manufacturer review/investigation.Device is not distributed in the united states, but is similar to device marketed in the usa.Part number : sd802.840, lot number: 898p169, manufacturing site: (b)(4), release to warehouse date: 22 jun 2022 a manufacturing record evaluation was performed for the not sterile finished lot number, and no non-conformances were identified.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 was used for treatment, not diagnosis.If information is obtained that was not available for the initial , a follow-up will be filed as appropriate.
|
Device report from synthes reports an event in germany as follows: it was reported that on an unknown date, a cmf-cranioplastie was too large frontally, so there was too much space after implantation.No further information is available.This report involves one custom-made device trumatch cmf peek mil.This is report 2 of 2 for (b)(4).
|