BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACP 2 LVL SPIKED PLATE 34MM

    MDR report key: 1022799 · Received March 28, 2008

    Report

    Report Number
    1649384-2008-00138
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 28, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DID NOT OCCUR IN SURGERY. PRODUCT IS AN INSTRUMENT. REQUESTS HAVE BEEN MADE FOR THE RETURN OF THE PRODUCT. REQUEST HAS BEEN MADE TO OBTAIN THE PRODUCT. EVAL IS PENDING UPON THE RETURN OF THE PRODUCT.

    Description of Event or Problem · 1

    ON 13 MAR 2008, THE SALES REP REPORTED THAT DURING 2 LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF), THE PLATE BROKE WHEN THE SURGEON ATTEMPTED TO BEND THE PLATE PRIOR TO IMPLANTATION. THE PLATE DID NOT COME IN CONTACT WITH THE PT. THERE WAS NO SURGICAL DELAY. THE SURGERY WAS COMPLETE WITHOUT ANY FURTHER INCIDENT. THE MALFUNCTION HAS RESULTED IN AN ADVERSE EVENT IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACP 2 LVL SPIKED PLATE 34MM ACUFIX SLIMLINE KWQ ABBOTT SPINE 7ZE

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR