SYNTHES USA 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/80MM; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
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Device Problem
Break (1069)
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Patient Problems
Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
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Event Date 09/17/2015 |
Event Type
Injury
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Device evaluated by mfg.Patient information not available for reporting.Additional product code: hrs, hwc.(b)(4).Not implanted, retained fragment.The proximal portion of the screw was explanted.Initial reporting facility unknown.(b)(4): this event resulted in a retained fragment.Subject device has not been received.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.Device is not expected to be returned for manufacturer review/investigation.Device not available for evaluation.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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Customer quality unit received a maude report forwarded from (b)(6); this maude report against user facility report # 5177064.Only additional and/or corrected information will be contained in this report.It was reported that during a surgical procedure on (b)(6) 2015, a screw fractured when placed in left femur.The proximal portion of the screw was removed, the distal portion was left in the bone.There is no additional information available regarding patient outcome, procedure or delay.This complaint involves one device.This report is 1 of 1 for (b)(4).
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Manufacturer Narrative
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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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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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