BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP ANTERIOR ANKLE ARTHRODESISPLATE 6 HOLES/100MM

    MDR report key: 3091594 · Received May 3, 2013

    Report

    Report Number
    3003506883-2013-00211
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 4, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K061940
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF LCP ANTERIOR ANKLE ARTHRODESIS PLATES WAS PROCESSED THROUGH NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO SIGNIFICANT NONCONFORMANCES OR REWORK NOTED. ONE (1) PIECE OF SCRAP WAS RECORDED AT A MANUFACTURING STEP FOR A SET UP PIECE WITH A SLOT SIZE ISSUE. NO NONCONFORMING MATERIAL NOTICE WAS ISSUED FOR THIS IN CELL - SET UP SCRAP. THIS ORDER MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF THE RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO ANOMALIES NOTED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    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 1 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194302 LCP ANTERIOR ANKLE ARTHRODESISPLATE 6 HOLES/100MM HRS SYNTHES ELMIRA 6848131

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention