BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZODIAC PEDICLE SCREW SYSTEM

    MDR report key: 2190137 · Received May 10, 2007

    Report

    Report Number
    2027467-2007-00009
    Event Type
    Injury
    Date Received
    May 10, 2007
    Date of Event
    March 23, 2007
    Report Date
    May 10, 2007
    Manufacturer
    ALPHATEC SPINE INC.
    Product Code
    KWP
    PMA / PMN Number
    K033090
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD OF BOTH PARTS INVOLVED WERE REVIEWED. THE EVALUATION OF THE DEVICE HISTORY RECORDS DO NOT REVEAL ANY QUALITY CONCERNS. THE DISTRIBUTOR (B)(4) WHO REPORTED THE INCIDENT ON (B)(4) 2007 AT 1:15PM BY PHONE AND EXPLAINED THE INCIDENT IN MORE DETAIL. HE INDICATED THAT USER WAS USING CUSTOM MADE INSTRUMENTS DURING THE PROCEDURE. HE SAID HE WOULD CONTACT REGULATORY AFFAIRS BY ELECTRONIC MAIL TO GIVE THE PROPER INFORMATION ABOUT CUSTOM PARTS USED DURING THE PROCEDURE. REGULATORY AFFAIRS EXPLAINED THEY WOULD SEND AN ELECTRONIC MAIL REQUESTING THE INFORMATION. REGULATORY AFFAIRS HAVE MADE SEVERAL ATTEMPTS FOR THIS INFORMATION, WITH NO RESPONSE FROM THE DISTRIBUTOR. THE PARTS REMOVED FROM THE PATIENT WERE NOT RETURNED TO ALPHATEC SPINE. THE PARTS WERE NOT AVAILABLE FOR EVALUATION. INFORMATION REGARDING CUSTOMER MADE INSTRUMENTS USED DURING THE PROCEDURE HAS NOT BEEN OBTAINED. THE COMPLAINT CANNOT BE CONFIRMED AND A ROOT CAUSE CANNOT BE IDENTIFIED.

    Description of Event or Problem · 1

    DURING A POST OPERATIVE VISIT, AN X-RAY DETECTED THAT THE ROD MOVED IN A SUPERIOR DIRECTION, MAKING ANOTHER SURGERY NECESSARY TO CORRECT THE PROBLEM. DURING THE REVISION SURGERY IT WAS FOUND THAT THREE SET SCREWS LOOSENED, THIS CAUSED THE ROD TO MOVE. THE ROD AND THREE SET SCREWS WERE REPLACED. THE THREE SET SCREWS HAD THE SAME LOT NUMBER. THE ROD PART NUMBER IS 62004-07. THE ROD LOT NUMBER IS 605603B.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZODIAC PEDICLE SCREW SYSTEM ZODIAC POLYAXIAL SACRAL SCREW KWP ALPHATEC SPINE INC. 62005 610029C

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention