Model Number 16191111 |
Device Problems
Break (1069); Misassembled During Installation (4049)
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Patient Problems
Pain (1994); No Consequences Or Impact To Patient (2199)
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Event Date 10/02/2019 |
Event Type
malfunction
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Manufacturer Narrative
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No product has been returned for investigation as it remains in-situ.Radiographs provided confirm the alleged event.Labeling review: ".Warnings, cautions and precautions: care should be taken to insure that all components are ideally fixated prior to closure.All implants should be used only with the appropriately designated instrument." ".Preoperative warnings: care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." ".Note: check both reduction extensions after removal for the black lasermark at the distal end of the reduction extension to ensure the reduction extension has broken off at the correct spot (fig.12).Note: be sure the lock screw is fully seated and the rod is fully reduced prior to breaking off the reduction extensions.".
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Event Description
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On an unknown date a patient underwent a posterior procedure at l4-s1 without any reported incidents.During a postoperative visit the reduction extension tabs were discovered still in-situ.No revision procedure is currently planned.
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Event Description
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Supplemental report submitted.
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Manufacturer Narrative
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Review of the reported event describes the reduction tab fractured off above the desired location and the tab comparison process outlined in the instructions for use was not completed resulting in the fractured tab being left in-situ.Surgeons perogative was not to revise and leave as is.No additional investigation required.Labeling review: "note: be sure the lock screw is fully seated and the rod is fully locked down.".
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Search Alerts/Recalls
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