WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 60; PLATE,FIXATION,BONE
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Model Number 02.211.060 |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/05/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).Additional narrative: additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing 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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It was reported on that (b)(6) 2021, the patient underwent for a surgery.During the surgery, the va locking screw would not lock into plate hole.The procedure was completed successfully without surgical delay.Patient outcome was unknown.Concomitant device reported: unknown screwdriver (part# unknown; lot# unknown; quantity: 1).This complaint involves two(2) devices.This report is for (1) 2.7 va lckng scr slf-tpng t8 sd rec 60.This report is 2 of 2 for (b)(4).
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