BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM NARROW LCP® PLATE 11 HOLES/206MM

    MDR report key: 2875229 · Received December 17, 2012

    Report

    Report Number
    3003506883-2012-00398
    Event Type
    Injury
    Date Received
    December 17, 2012
    Report Date
    November 19, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    KTT
    PMA / PMN Number
    K000682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. 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 BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT HAD A MID SHAFT HUMERUS FRACTURE AND WAS IMPLANTED WITH AN 11 HOLE PLATE AND 8 SCREWS ON (B)(6) 2012. THE PATIENT CAME IN FOR A FOLLOW UP VISIT, DATE UNKNOWN, AND X-RAYS SHOWED 3 SCREWS BROKE AT THE HEAD WITH THE SHAFT OF THE 3 BROKEN SCREWS REMAINING IN THE PATIENT'S BONE. THE SURGEON DID A FULL HARDWARE REMOVAL ON (B)(6) 2012. PATIENT WAS REVISED TO ANOTHER PLATE AND SCREWS. THE SURGEON COMPLETED HIS PROCEDURE SUCCESSFULLY. THIS IS 1 OF 4 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM NARROW LCP® PLATE 11 HOLES/206MM NARROW LCP® PLATE KTT SYNTHES ELMIRA 6208866

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention PLATE, SCREWS