DEPUY SPINE INC MINI POLYAXIAL BONE SCREW 3.5 X 4 X 16MM; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
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Model Number 188318416 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Osteolysis (2377)
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Event Type
Injury
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/ investigation.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2011, the patient underwent a cervical-thoracic posterior fusion (c4-t2 excluding c7) for ossification of posterior longitudinal ligament (opll).On (b)(6) 2021 the patient was diagnosed with adjacent segment disease (asd) which required decompression fusion between t2 and t3.All implants fused in 2011 had no defect so the fusion will be extended.The revision of c7, t3 (or up to t4) was planned for (b)(6) 2021.This report is for one (1) mini polyaxial bone screw 3.5 x 4 x 16mm.This is report 7 of 11 for (b)(4).
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Manufacturer Narrative
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Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.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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