BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.3MM X 22MM LOCKING CORTICAL PEG

    MDR report key: 1920231 · Received December 10, 2010

    Report

    Report Number
    3025141-2010-00074
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    ACUMED LLC
    Product Code
    HRS
    PMA / PMN Number
    K012655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: RETURNED PLATE WAS FOUND TO BE WITHIN SPECIFICATION AND WAS NOT BENT AS ALLEGED IN THE INITIAL REPORT. THERE WERE NO SIGNS OF STRETCHING OR COMPRESSION AS MIGHT BE EXPECTED IN A BENT PLATE. NON-LOCKING SCREWS WERE RETURNED WITH THE PLATE WHICH IS COUNTER TO THE SURGICAL TECHNIQUE WHICH SPECIFIES LOCKING SCREWS IN THE PROXIMAL SECTION OF THE PLATE. ONE LOCKING PEG WAS BROKEN UNDER THE HEAD AND THE SURFACE WAS MOSTLY ROUGH WITH SOME SMOOTHING. THIS MAY INDICATE A SINGLE LOAD FAILURE EVENT WITH SOME RUBBING AFTER BREAKAGE AND BEFORE REMOVAL. CONCLUSION: WHILE IT CAN BE DETERMINED THAT THE PLATE IS WITHIN SPECIFICATION AND THE SURGICAL TECHNIQUE WAS NOT FOLLOWED, IT CANNOT BE DETERMINED HOW MUCH OF AN IMPACT THIS MIGHT HAVE PLAYED IN THE CONSTRUCT OF PLATE AND SCREWS NOT MAINTAINING ADEQUATE FIXATION UNTIL THE BONE HAD HEALED. THEREFORE NO DEFINITIVE CONCLUSION CAN BE DETERMINED WITH THE AVAILABLE INFORMATION. ADDITIONAL MDR'S ASSOCIATED WITH THIS EVENT ARE: 3025141-2010-00067; 3025141-2010-00068; 3025141-2010-00069; 3025141-2010-00070; 3025141-2010-00071; 3025141-2010-00072; 3025141-2010-00073; 3025141-2010-00075; 3025141-2010-00076; 3025141-2010-00077.

    Description of Event or Problem · 1

    AN ACUMED 2.3MM X 22MM LOCKING CORTICAL PEG WAS IMPLANTED ON (B)(6) 2010 WITH AN ACU-LOC PLATE BY DR (B)(6) AT (B)(6) HOSPITAL IN (B)(6). THE INITIAL REPORTER ALLEGED THAT, AT AN UNKNOWN TIME, THE PLATE BECAME BENT AND STARTED TO SEPARATE FROM THE PATIENT'S BONE. THE SCREWS THAT WERE LOCKED INTO THE PLATE REPORTEDLY BACKED OUT OF THE PLATE AFTER THE BEND IN THE PLATE OCCURRED. ONE LOCKING CORTICAL PEG BROKE, AND THE PLATE AND SCREWS WERE REMOVED FROM THE PATIENT ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.3MM X 22MM LOCKING CORTICAL PEG CONGRUENT BONE PLATE SYSTEM HRS ACUMED LLC CO-S2322 223767

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention