BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET SCREW STAR DRIVER-SHORT

    MDR report key: 1040283 · Received May 8, 2008

    Report

    Report Number
    1649384-2008-00257
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 9, 2008
    Report Date
    May 8, 2008
    Manufacturer
    ABBOTT SPINE, INC.
    Product Code
    HXX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUEST HAS BEEN MADE TO OBTAIN THE PRODUCT. EVALUATION IS PENDING UPON THE RETURN OF THE PRODUCT.

    Description of Event or Problem · 1

    ON 04/10/08, THE SALES REP REPORTED THAT DURING SURGERY, THE DRIVER WOULD NOT WORK. THE DRIVER WAS STRIPPED. NO HARM TO THE PT. ADDITIONAL INFO RECEIVED ON 05/02/08 VIA TELEPHONE, THE SALES REP REPORTED THAT THE SURGEON USED OTHER INSTRUMENTS THAT WERE IN THE HOSP TO FINISH THE CASE AS INTENDED SINCE BOTH DRIVERS DID NOT FUNCTION. THERE WAS A ONE HOUR SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SET SCREW STAR DRIVER-SHORT NEXLINK HXX ABBOTT SPINE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other