OBERDORF SYNTHES PRODUKTIONS GMBH TI 12-POINT NUT-11MM; ORTHOSIS,PEDICLE SPINAL FIXATION
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Catalog Number 499.294 |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problems
Nerve Damage (1979); Limited Mobility Of The Implanted Joint (2671)
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Event Type
Injury
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Manufacturer Narrative
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Additional product codes: nkb, mnh, kwp, kwq.Device evaluated by mfr: 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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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 spondylodeses 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.This report is for one (1) ti 12-point nut-11mm.This is report 8 of 10 for (b)(4).This complaint and complaints (b)(4) capture the post-operative event that involved the fifty-five (56) polyaxial screws explanted due to hypermobility and nerve root compression and switched to a pedicle screw system, while (b)(4) captures the intra-operative events that involved the broken screws during tightening of the nut.
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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.H11: corrected data: d10, h3, h6: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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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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: 499.294, lot: 9306544, manufacturing site: mezzovico, release to warehouse date: 07.Jan.2015.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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