Catalog Number 187823108 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Osteolysis (2377)
|
Event Type
Injury
|
Event Description
|
Device report from japan reports an event as follows: the patient had a posterior lumbar interbody fusion (l4/5) performed on (b)(6) 2014.At an unknown date after the surgery, asd occurred.It was reported that on (b)(6) 2023, a revision procedure was performed to extend fixation.- olif was performed in l2/3 and l3/4 in side lying position.- a positional change to prone and removal of existing 4/5 crosslink, set screw and rod.- plif for l5/s (using non-depuy synthes product).- verse screw insertion at l2 (diameter 6.0 - length 45mm), verse screw insertion at l3 (diameter 7.0 - 45mm).- expedium-cfs insertion in s1 (diameter 7.0 - length 40mm), expedium-cfs insertion in s2 aller (diameter 7.0 - 40mm).- osteotomy rod installation set screw correction.- bone graft final tightening.- cross-link installation.The revision procedure was completed successfully with no adverse patient impact.No further information is available.This report is for a concorde bullet spinal system parallel 9 x 8 x 23mm.This is report 2 of 4 for (b)(4).
|
|
Manufacturer Narrative
|
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.: d2: additional procode: max.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: initial reporter is a synthes 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.
|
|
Manufacturer Narrative
|
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: h4, h6: a review of the receiving inspection (ri) for concorde bul par 9x8x23, was conducted identifying that lot number apcfn0 was released in one batch.Batch1: lot units were released on 13 may 2013 with no discrepancies.Supplier : medos int spine.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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.
|
|
Search Alerts/Recalls
|
|