BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACP 3 LVL SPIKELESS PLATE 56MM

    MDR report key: 1023410 · Received April 2, 2008

    Report

    Report Number
    1649384-2008-00193
    Event Type
    Injury
    Date Received
    April 2, 2008
    Date of Event
    March 7, 2008
    Report Date
    April 2, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    JDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTS HAVE BEEN MADE FOR THE RETURN OF THE PRODUCT. REQUEST HAS BEEN MADE TO OBTAIN THE PRODUCT. DEVICE MANUFACTURE DATE IS UNK. EVALUATION IS PENDING UPON THE RETURN OF THE PRODUCT.

    Description of Event or Problem · 1

    IN 2008, THE SALES REPORTED THAT DURING A CERVICAL PROCEDURE, THE SURGEON WAS IMPLANTING A PLATE AND HAD ALREADY IMPLANTED TWO SCREWS, WHEN HE DETERMINED THAT IT WAS THE WRONG SIZE PLATE. THE SURGEON THEN ATTEMPTED TO EXPLANT THE SCREWS AND PLATE AND THE SURGEON WAS NOT ABLE TO BACK OUT THE SECOND SCREW AND BROKE THE VERTEBRAL BODY IN ORDER TO REMOVE THE PLATE AND SCREW. THE SURGEON DID A CORPECTOMY AND IMPLANTED ANOTHER PLATE. THE SURGERY WAS EXTENDED 1 AND 1/2 HRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACP 3 LVL SPIKELESS PLATE 56MM ACUFIX JDN ABBOTT SPINE 36KL

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention