BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI PLATE, 4-HOLES, WITH BAR (1/P)

    MDR report key: 1844622 · Received September 22, 2010

    Report

    Report Number
    8010177-2010-00343
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 25, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K014263
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE DEVICES WERE REMOVED AND REPLACED. NO DEVICES WERE BROKEN. INVESTIGATION IN PROCESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    PER SALES REP, PRODUCTS WERE EX-PLANTED FROM A NON-COMPLIANT PT. PT REMOVED WIRES AND ARCH BARS FROM HIS MOUTH, AND AS A RESULT, THE SCREWS AND PLATES BECAME LOOSE AND HAD TO BE REMOVED. A REVISION SURGERY TOOK PLACE AND NEW IMPLANTS WERE PLACED SUCCESSFULLY. PART NUMBERS INCLUDE THE FOLLOWING: 55-10505, 50-20358, 50-20362, 50-20406, 50-20412. SALES REP WAS NOT PRESENT AT CASE AND DOES NOT HAVE ANY OF THE PRODUCTS TO RETURN. SALES REP WAS INFORMED OF THE REVISION SURGERY AFTER-THE-FACT AND REPORTED IT AS SOON AS HE RECEIVED ALL THE INFO FROM THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI PLATE, 4-HOLES, WITH BAR (1/P) IMPLANT JEY STRYKER OSTEOSYNTHESIS FREIBURG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other