BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM NARROW LCP® PLATE 7 HOLES/134MM

    MDR report key: 2822472 · Received November 7, 2012

    Report

    Report Number
    3003506883-2012-00351
    Event Type
    Injury
    Date Received
    November 7, 2012
    Report Date
    October 10, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    KTT
    PMA / PMN Number
    K000682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE SEVERAL FACTORS CONSIDERED WHEN EVALUATING THIS COMPLAINT. FIRST, THIS RISK IS ADEQUATELY ADDRESSED IN THE RISK ANALYSIS. SECOND, BOTH 3.5MM AND 4.5MM SCREWS ARE COMMONLY USED TO TREAT SHAFT FRACTURES IN THE HUMERUS. CONSIDERING THAT SMALLER 3.5MM CORTEX SCREWS HAVE BEEN USED FOR WELL OVER 10 YEARS TO SAFELY TREAT HUMERAL SHAFT FRACTURES COMBINED WITH THE VERY LOW OCCURRENCE OF ISSUES WITH THE 4.5MM SCREWS, IT SEEMS VERY UNLIKELY THAT THE DESIGN OF THE 4.5MM CORTEX SCREW WAS THE CAUSE OF THE COMPLAINT. LASTLY, CONSIDERING THE NUMBER OF OTHER FACTORS INVOLVED IN THE TREATMENT OF THESE FRACTURES, PROPER REDUCTION, SCREW PLACEMENT, SURGICAL TECHNIQUE, AND THE RELATIVELY HIGH SUCCESS RATE OF THESE SCREWS, IT IS UNLIKELY THAT THE DESIGN OF THE SCREWS IS THE CAUSE OF THE COMPLAINT. THE SCREWS FUNCTION AS INTENDED WITHIN ACCEPTABLE RISK LEVELS. (B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT IMPLANTED WITH NARROW LCP PLATE 7 HOLE AND SIX SCREWS ON (B)(6) 2012. PATIENT RETURNED FOR ROUTINE FOLLOW UP ON (B)(6) 2012, WITH AN X-RAY SHOWING TWO SCREW HEADS WERE BROKEN. PATIENT WAS RETURNED TO OPERATING ROOM ON (B)(6) 2012, HARDWARE WAS REMOVED WITH THE EXCEPTION OF THE SHAFTS OF THE TWO BROKEN SCREWS REMAIN IN THE PATIENTS BONE. PATIENT WAS REVISED TO ANOTHER 7 HOLE PLATE AND SCREWS ON A DIFFERENT AREA OF THE BONE. IT IS REPORTED INFUSE BONE GRAFT WAS USED DURING REVISION TO NEW LCP LARGE FRAGMENT PLATE AND SCREWS. THIS IS 1 OF 3 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM NARROW LCP® PLATE 7 HOLES/134MM NARROW LCP® PLATE 7 HOLES KTT SYNTHES ELMIRA 5184207

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention PLATE, SCREWS