BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL DRIVER

    MDR report key: 1053256 · Received May 28, 2008

    Report

    Report Number
    1649384-2008-00278
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 28, 2008
    Manufacturer
    ABBOTT SPINE, INC.
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D6-7: PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTABLE. D10: REQUESTS HAVE BEEN MADE FOR THE RETURN OF THE PRODUCT. H3: REQUESTS HAS BEEN MADE TO OBTAIN THE PRODUCT. H6: EVALUATION IS PENDING UPON THE RETURN OF THE PRODUCT. NOTE: A REPORT OR OTHER INFO SUBMITTED BY A REPORTING ENTITY UNDER THIS PART, AND ANY RELEASE BY FDA OF THAT REPORT OF INFORMATION, DOES NOT NECESSARILY REFLECT A CONCLUSION BY THE PARTY SUBMITTING THE REPORT TO FDA THAT THE REPORT OF INFORMATION CONSTITUTES AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, OR ITS EMPLOYEES OR AGENTS CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. THE REPORTING ENTITY NEED TO ADMIT AND MAY DENY (AND MAY EXPRESSLY RESERVE THE RIGHT TO DENY) THAT THE DEVICE, THE PARTY SUBMITTING THE REPORT OR EMPLOYEES THEREOF CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    IN 2008, THE SALES REP REPORTED THAT DURING SURGERY THE SURGEON BENT TWO REMOVAL DRIVER WHILE TRYING TO REMOVE PATHFINDER SCREWS. THE SURGEON HAD ANOTHER DRIVER AVAILABLE TO FINISH THE CASE AS INTENDED. ADDITIONAL INFO RECEIVED AT ABOUT 10 DAYS LATER VIA TELEPHONE FROM THE SALES REP. THE SALES REP REPORTED THAT THIS WAS A REVISION SURGERY FOR PSEUDOARTHROSIS. THE SURGEON WAS ON THE LAST CLOSURE TOP WHEN THE FIRST DRIVER BENT SO THEN HE USED THE SECOND DRIVER THAT WAS IN THE KIT AND THAT ONE ALSO BENT BUT THE SURGEON WAS ABLE TO FINISH THE CASE AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL DRIVER INCOMPASS HXX ABBOTT SPINE, INC. 39CY

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK