WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 3.5MM LCP® METAPHYSEAL PLATE 11 HOLES; APPLIANCES, FIXATION, NAIL/BLD/PL COMBO, MULTI COMP, METAL COM
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Model Number 223.411 |
Device Problem
Break (1069)
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Patient Problems
Unspecified Infection (1930); Non-union Bone Fracture (2369)
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Event Type
Injury
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Manufacturer Narrative
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Patient information is unknown.It is unknown when the event occurred.510k: this report is for 1 (one) 3.5 mm lcp metaphyseal plate/unknown lot.Lot number is unknown.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 that the patient underwent revision of a plate and screws on (b)(6) 2017 due to broken plate, non-union, and septic infection.The patient presented with a broken 3.5 mm locking compression plate (lcp) metaphyseal plate, 11 hole plate in the left mid-shaft ulna.The original implant date is unknown.The plate and nine (9) screws (six (6) 3.5 mm cortex screws in the plate, one (1) independent lag screw, and two (2) 3.5 mm locking screws) were successfully removed, there were no fragments.A chisel was used to remove bone growth from over the screws and plate.The area was debrided and irrigated.A new plate was implanted; the surgeon cut the proximal tip of the plate to accommodate the patient anatomy.Relevant screws were used for fixation: variable angle elbow set and lcp small fragment set.The procedure was successfully completed.This report is for a 3.5 mm lcp metaphyseal plate.(b)(4).
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