Additional product code: hwc, hrs.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot: part: 02.124.407, lot: 9505744, manufacturing site: (b)(4), release to warehouse date: june 15, 2015.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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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T was reported that on (b)(6) 2019, patient underwent hardware removal of two (2) variable angle locking compression plate (va-lcp) condylar plate and sixteen (16) unknown locking screws due to pain.Originally, the patient had bilateral osteotomies on unknown date.However, the patient was experiencing pain when performing squats.Thus, removal was done successfully.There was no patient consequence reported.This is report 2 of 10 for (b)(4).Related product complaint: (b)(4).
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