OBERDORF SYNTHES PRODUKTIONS GMBH TI 12-POINT NUT-11MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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Catalog Number 499.294 |
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 product codes: mni, mnh, kwp, kwq.Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 and hardware removal.The patient had previous operations on levels 3, 4 & 5 with uss polyaxial cement augmentation spondylodeses on an unknown date.All the screws were explanted and patient was revised to a pedicle screw system.There was a 120 minutes surgical delay.It was unknown if there were fragments generated from device removal.Patient and surgical status is unknown.(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 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.H3, h4, h6- 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.Device history lot part: 499.294, lot: l243272, manufacturing site: mezzovico, release to warehouse date: 19.Dec.2016.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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Event Description
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No cement was used on this surgery.
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Search Alerts/Recalls
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