Device report from synthes reports an event in japan as follows: it was reported that this was a psf (t9-l1) performed on (b)(6) 2014.After surgery, a pressure ulcer was observed at the upper end of t9.Ic was held between the surgeon and the patient to confirm whether to remove only the rod at the affected site or to remove all the implants.It was determined to remove all implants.The removal surgery was performed on (b)(6) 2023, as scheduled.All the implants were removed without any problems, and the removal surgery was completed successfully this report is for one (1) single-inner set screw.This is report 3 of 10 for complaint.
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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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d2b: additional product codes: kwp,kwq, mnh,mni and osh.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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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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.H10 additional narrative: e1 additional reporter.H4 device history.Part: 179702000.Lot: arcdzy.Supplier: (b)(4).Batch1: lot qty of (b)(4) units were released on april 2014 with no discrepancies.No ncrs were generated during production.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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