OBERDORF SYNTHES PRODUKTIONS GMBH TI COLLAR FOR 6.0MM RODS FOR USS POLYAXIAL; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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Catalog Number 04.607.412 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Nerve Damage (1979); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Additional device product codes: mni, mnh, kwp, kwq.(b)(4).The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent a spinal fusion procedure, an adjustment on level 2 due to hypermobility and nerve root compression.The patient had previous operations on levels 3, 4 & 5 with uss polyaxial cement augmentation spondylodese on an unknown date.So all the screws were explanted and completed the surgery by switching into a pedicle screw system.There was a 120 minutes surgical delay.It was unknown if there were fragments generated from the broken devices.It was unknown if there were adverse event to the patient reported.The complaint involves 56 devices.Due to a limit of impacted products per complaint, this complaint will be captured under 6 separate complaints as listed below: (b)(4).These complaints capture the post-op event that involved the fifty-five (56) polyaxial screws that were explanted due to hypermobility and nerve root compression and switched to a pedicle screw system, while, related complaint (b)(4) captures the intra-op events that involved the broken screws during tightening of the nut.This report is for one (1) ti collar for 6.0mm rods for uss polyaxial.This is report 8 of 10 for complaint (b)(4).
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Manufacturer Narrative
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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.The visual inspection found no product issues that could have contributed to the clinical finding.This complaint was entered to capture the revision surgery due to hypermobility and nerve root compression.No product issues that could have contributed to this clinical finding were found.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Part: 04.607.412, lot: 2l30261, manufacturing site: mezzovico, release to warehouse date: 21.Nov.2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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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Search Alerts/Recalls
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