Report source, foreign - event occurred in (b)(6).Concomitant medical product - std brl 4-hole plate 135 deg, item 2110-135-004, lot 6239135.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2018-01078.
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(b)(4).The product relating to the reported event has been returned to (b)(4) for evaluation.A review of the manufacturing history records for the hiploc plate from this event has not reported any abnormalities or deviations.A review of the complaint database found 17 similar complaints reported for this item code.The returned hiploc plates have been confirmed as non-conforming.The internal barrel on the hiploc plate has been confirmed as undersized through dimensional checks.A supplier corrective action report, (b)(4), has been raised on sanatmetal to investigate their manufacturing processes in relation to the non-conformance.A (b)(4).Has been raised to investigate receipt and release of product.Product hold has been initiated: (b)(4).A hhe has been completed: (b)(4).A field action determination has been completed: (b)(4).
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