OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
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Device Problem
Use of Device Problem (1670)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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This report is for an unknown va condylar plate/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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.(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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Device report from the (b)(6) reports an event as follows: it was reported that on (b)(6) 2019, the patient underwent a revision surgery.The variable angle (va) condylar plate had been in place for around two (2) years and did not have enough working length.Surgical procedure and patient outcome were unknown.Concomitant devices: screws (part: unknown, lot: unknown, quantity: unknown).This report is for an unknown va condylar plate.This is report 1 of 1 for (b)(4).
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Search Alerts/Recalls
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