Model Number SLP6535 |
Device Problems
Break (1069); Appropriate Term/Code Not Available (3191)
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Patient Problem
Insufficient Information (4580)
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Event Date 08/19/2021 |
Event Type
Injury
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Manufacturer Narrative
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Patient information - unknown.Occupation - other; distributor.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.
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Event Description
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It was reported that the patient underwent initial implantation on (b)(6) 2021, during which surelok pedicle screw system product was implanted.Subsequently, a revision procedure was performed in (b)(6) on (b)(6) 2021, to address a broken 6.5mm x 35mm s-lok polyaxial screw (slp6535).As confirmed by the surgeon, fusion was achieved at the time of the revision procedure.
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Manufacturer Narrative
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H3 device evaluation - the x-rays and the returned part were reviewed.The broken screw appears to be one of the two screws placed in the sacrum.The number of levels being fused is unclear since the image is truncated.At least three levels are shown.The screw's fractured surface was examined with the aid of a 5x loop.The surface near the area of crack progression includes a few ratchet marks.Crack progression marks emanate from this side of the screw.Based upon the markings fatigue failure is suspected.The cause for the failure is unknown but numerous clinical papers are associated with hardware failures across the lumbo-sacral junction.Review of device history records found forty (40) pieces of lot 31973ps were released for distribution on 8/27/2020 with no deviation or anomalies.Two-year complaint history review (9.28.209-9.28-2021) found this to be the only report of this nature for the reported lot.Further review did not reveal a trend for reports of this nature for the reported product family of screws.No corrective actions are recommended at this time.
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Event Description
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It was reported that the patient underwent initial implantation on (b)(6) 2021, during which surelok pedicle screw system product was implanted.Subsequently, a revision procedure was performed in puerto rico on (b)(6) 2021, to address a broken 6.5mm x 35mm s-lok polyaxial screw (slp6535).As confirmed by the surgeon, fusion was achieved at the time of the revision procedure.
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Search Alerts/Recalls
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