BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9 - 10 MM EZLOC FEMORAL FIXATION LONG

    MDR report key: 2518363 · Received May 20, 2009

    Report

    Report Number
    2027970-2009-00004
    Event Type
    Injury
    Date Received
    May 20, 2009
    Date of Event
    May 12, 2009
    Report Date
    May 18, 2009
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    MBI
    PMA / PMN Number
    K041261
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY LOCATED OUTSIDE USA. (B)(6). CUSTOMER STATED THAT AFTER CLEANING THE IMPLANT, THE JAW DEPLOYED/ROTATED AS REQUIRED. THE TWO SEPARATE LOTS IN WHICH THE ALLEGED MALFUNCTION OCCURRED WHERE MANUFACTURED TWO SEPARATE YEARS. THERE HAVE BEEN OTHER OCCURRENCES OF THIS NATURE REPORTED. IT APPEARS THAT DEPLOYMENT OF THE LEVER ARM WAS ATTEMPTED PRIOR IT REACHING THE SURFACE OF THE CORTEX. DEVICE 2: BRAND NAME: 9 - 10 MM EXLOC FEMORAL FIXATION LONG. COMMON DEVICE NAME: MBI. MANUFACTURE: BIOMET SPORTS MEDICINE, (B)(4). MODEL#: 904785, CAT#: 904785, SERIAL#: NA, LOT#: L077870, EXPIR DATE: 08/01/2011. OTHER: NA.

    Description of Event or Problem · 1

    DEVICE 1. IT WAS REPORTED THAT THE ARMS ON TWO EZLOC FEMORAL FIXATION DEVICES WITH TWO SEPARATE LOT NUMBERS WOULD NOT DEPLOY. FIXATION OF THE LEVER ARM TO THE LATERAL FEMORAL CORTEX WAS UNSUCCESSFUL WITH BOTH PRODUCTS. THIS CASE WAS EXTENDED MORE THAN 30 MINUTES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9 - 10 MM EZLOC FEMORAL FIXATION LONG MBI BIOMET SPORTS MEDICINE 904785 L024920

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other