BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 7 HOLES/81MM

    MDR report key: 3091577 · Received May 3, 2013

    Report

    Report Number
    3003506883-2013-00212
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 4, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K011335
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PART NUMBER 241.381 MADE ON WORK ORDER (B)(4) AND LOT NUMBER 6508516 HAD NO NCRS. MATERIAL LOT 6203381 FROM WHICH THESE PARTS HAD ONE NCR FOR INCOMPLETE INFORMATION ON THE CERTIFICATE. CERTIFICATE WAS MISSING TEST RESULTS USED TO VERIFY RAW MATERIAL ACCEPTANCE. ALL NECESSARY TESTS WERE FOUND TO BE PERFORMED AND VERIFIED MATERIAL TO BE CONFORMING. INFORMATION WAS INADVERTENTLY NOT TRANSFERRED TO CERTIFICATE. REWORK OF CERTIFICATE DOCUMENTATION IS RECORDED ON (B)(4). REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE AND THERE WERE NO ISSUES DOCUMENTED DURING THE MANUFACTURING OF THESE PARTS THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    THE SURGEON PLANNED A HARDWARE REMOVAL OF AN ANKLE ARTHODESIS PLATE BECAUSE A COUPLE OF SCREWS HAD LOOSENED AND BACKED OUT. THE SURGEON SUCCESSFULLY REMOVED THE PLATE AND SIX SCREWS, INCLUDING THE SCREW THAT WAS PLACED OUTSIDE THE ANKLE INDEPENDENTLY. THE SURGEON ALSO REMOVED THE BROKEN FIBULA PLATE AND SIX SCREWS AS WELL. THE SURGEON DID NOT REPLACE THE PATIENT WITH ANYTHING ADDITIONAL AFTER REMOVING ALL HARDWARE, TWO PLATES AND TWELVE SCREWS. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194670 LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 7 HOLES/81MM HRS SYNTHES ELMIRA 6508516

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention