BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP PLATE 8 HOLES 111MM

    MDR report key: 3032638 · Received April 3, 2013

    Report

    Report Number
    3003506883-2013-00137
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 7, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    KTT
    PMA / PMN Number
    K000684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH 8-HOLE PLATE AND SIX SCREWS ON AN UNKNOWN DATE. ON AN UNKNOWN DATE, IT WAS DISCOVERED THAT THE PLATE WAS IMPINGING UPON PRONATION. PATIENT RETURNED TO THE O.R ON (B)(6) 2013 FOR REVISION SURGERY. THE ORIGINAL 8-HOLE PLATE AND SIX SCREWS WERE REMOVED AND REPLACED WITH A 9-HOLE PLATE AND AN UNKNOWN NUMBER OF SCREWS IN A NEW LOCATION. THE SURGERY REPORTEDLY WENT WELL WITHOUT ANY ISSUES. THIS IS 1 OF 7 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135885 3.5MM LCP PLATE 8 HOLES 111MM KTT SYNTHES ELMIRA 6916440

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention