BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUFIX

    MDR report key: 1012678 · Received March 12, 2008

    Report

    Report Number
    1649384-2008-00094
    Event Type
    Injury
    Date Received
    March 12, 2008
    Date of Event
    February 15, 2008
    Report Date
    March 12, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    HTW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTABLE. REQUEST HAS BEEN MADE TO OBTAIN THE PRODUCT. EVALUATION IS PENDING UPON THE RETURN OF THE PRODUCT.

    Description of Event or Problem · 1

    IN 2008, THE SALES REPRESENTATIVE REPORTED THAT DURING AN ANTERIOR CERVICAL PROCEDURE, THE DRILL TIP BROKE WHEN THE SURGEON WAS DRILLING THE LAST HOLE. ADD'L INFO RECEIVED ON 14 MAR 2008 VIA TELEPHONE, THE SALES REPRESENTATIVE REPORTED THAT THE SURGEON WAS DRILLING THE LAST HOLE AND THE SURGEON HAD ALREADY DRILLED DOWN, WHEN THE TIP OF THE DRILL BROKE, THE SURGEON INTERVENED TO RETRIEVE THE TIP AND INSERTED THE SCREW WITHOUT ANY DIFFICULTY, FINISHING THE CASE AS INTENDED. THERE WAS NO REPORT OF PT INJURY OR SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUFIX ACU-FIX 2.50MM REDUCED LENGTH LONG DRILL HTW ABBOTT SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention