BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPDLNK 5.5 TRANS CNTR MED 43-51MM

    MDR report key: 1101683 · Received August 7, 2008

    Report

    Report Number
    1649384-2008-00417
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    July 8, 2008
    Report Date
    August 7, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTS HAVE BEEN MADE FOR THE RETURN OF THE PRODUCT. DEVICE MANUFACTURE DATE IS UNKNOWN. EVALUATION IS PENDING UPON RETURN OF THE PRODUCT.

    Description of Event or Problem · 1

    DURING SURGERY IN 2008, THE SALES REPRESENTATIVE REPORTED THAT THE SURGEON PUT THE SPEEDLINK ON THE ROD AND MALLETED THE SPEEDLINK IN PLACE WITH THE DIAMOND DRIVER. WHEN ATTEMPTING TO LOCK DOWN THE LEFT CAM IT WOULD NOT TURN COMPLETELY. THE PRODUCT WAS TAKEN OUT AND REPLACED WITH ANOTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPDLNK 5.5 TRANS CNTR MED 43-51MM SPEEKLINK KWP ABBOTT SPINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention