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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Ulcer (2274); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Pma/510k: this report is for an unk - screws: locking/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.(b)(4).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 on (b)(6) 2020, the patient underwent a hardware removal of the locking compression plating system (lcp) of the distal tibia due to infection.Initially, the patient was implanted with an lcp system on (b)(6) 2018.The surgeon commented that the patient had developed skin ulcers early on which caused infection from wearing his post-op boot too tight.The hardware was removed, and the removal surgery was completed.The patient is ok.This complaint involves twenty-three (23) devices.This report is for (1) unk - screws: locking.This is report 5 of 10 for (b)(4).Related product complaints: (b)(4).
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Search Alerts/Recalls
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