Device report from synthes reports an event in northern ireland as follows: it was reported that on (b)(6) 2022, the patient underwent surgery with a patient specific plate.The patient specific plate was produced incorrectly and was not the correct plate for the patient.It was from the scans of another patient.The patient specific team have indicated via email that they mixed up patient scans in their planning stage and sent incorrect plans to the surgeon.The patient was on the operating table at the point of discovery that the plate was not appropriate, and the plate had to be cut and shaped in order to make it fit.The fit was deemed appropriate following this however not exact as per expectations of a pre-made psi.The surgery was completed successfully with significant adaptions to the psi plate made.There was a delay of 90 minutes to complete the procedure.There was no injury to the patient.No further information is available.This report involves one psi sd800.439 peek implant.This is report 1 of 1 for (b)(4).
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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.Reporter is a j&j employee.Product code: sd800.439, lot no: 861p18, manufacturing site: (b)(4), release to warehouse date: 02 jun 2022, a manufacturing record evaluation was performed for the not sterile finished lot number, and no non-conformances were identified.The product was not returned to depuy synthes for evaluation.The depuy synthes r&d team conducted a design review for this case.The design review found that the incorrect file was used to design the implant, psi 120*120*40 peek, product code sd800.439, for this case.The design was correct for the file used but the incorrect file was used, therefore the complaint is confirmed and the cause traced to the design of the implant.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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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