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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Spinal Column Injury (2081); No Code Available (3191)
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Event Date 09/27/2019 |
Event Type
Injury
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Manufacturer Narrative
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This report is for an unknown - locking/set screws /unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive 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 on (b)(6) 2019, the patient underwent revision surgery to remove some matrix pedicle screws and the revision was apparently for further decompression and re-fixation.After two screws were successfully removed the other screws would not get any purchase from the screwdriver.It was advised that the screws which couldn¿t be removed remained in the patient and were re-locked with the rods and set screws.It unknown if there were fragments generated.Unknown patient outcome.Procedure successfully completed.This complaint involves ten (10) devices.This report is for one (1) unk - locking/set screws.This report is 9 of 10 for (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.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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Further it was reported that the side which were removed were replaced by alternative company product.There was a small extension to procedural time while screws were attempted to be removed.This report captures the post-operative event in which revision was performed for further decompression and re-fixation, while related complaint (b)(4) was created to capture the intra-operative event.
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Search Alerts/Recalls
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