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.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.The initial reporter facility name: (b)(6) hospital.The initial reporter is a j&j employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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 medwatch, a follow-up medwatch will be filed as appropriate.
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Device report from synthes reports an event in japan as follows: it was reported that the patient underwent a posterior spinal fusion (l1 to l3) on (b)(6) 2021.Although the patient was doing well postoperatively, during a followup visit, it was found that the screws were broken.The screws were removed because osteogenesis was achieved.However, the broken tip remained in the body.The surgeon determined that the broken tip could not be removed.According to the surgeon, the screw was too tightened.The surgeon guessed that the l3 screw was heavily loaded.This report involves one5.5 exp verse can scr 6.0x40.This is report 2 of 2 for (b)(4).
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