BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCHOR IMPLANTS - LATERJET

    MDR report key: 1910787 · Received November 23, 2010

    Report

    Report Number
    1221934-2010-00439
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 14, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    JDR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE IS IN THE PROCESS OF BEING RETURNED TO DEPUY MITEK FOR EVAL. WHEN AND IF THE DEVICE IS RETURNED, IT WILL BE EVALUATED IN AN EFFORT TO OBTAIN A ROOT CAUSE ANALYSIS. THE RESULTS OF THAT ROOT CAUSE ANALYSIS WILL BE REFLECTED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    A SURGEON CONTACTED A MITEK MARKETING EMPLOYEE STATING HE HAD BEEN SEEING A PT WHO ORIGINALLY HAD SHOULDER SURGERY AT A DIFFERENT INSTITUTION. THE PT WAS SENT FOR A 3 1/2 MONTH FOLLOW-UP IMAGING. THE IMAGING INDICATED THE BONE WAS NOT HEALED AND REHAB PROTOCOL WAS CONTINUED. LESS THAN 2 WEEKS LATER THE PT CONTACTED THE SURGEON WITH SEVERE PAIN AND LOSS OF SHOULDER MOBILITY. ADDITIONAL IMAGINING INDICATED THE BONE GRAFT HAD BECOME DISENGAGED AND THE TITANIUM SCREWS HAD BROKEN WHICH REQUIRED REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCHOR IMPLANTS - LATERJET 36MM TITANIUM SCREW & WASHER JDR DEPUY MITEK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1