BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROC

    MDR report key: 2893516 · Received March 19, 2009

    Report

    Report Number
    2027467-2009-00001
    Event Type
    Injury
    Date Received
    March 19, 2009
    Report Date
    March 17, 2009
    Manufacturer
    ALPHATEC SPINE INC.
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CORE (ROC) PEDICLE BOLTS WERE DISCOVERED TO BE BROKEN. THE DATE OF THE SCREW BREAKAGE IS UNK. THE SCREWS, NUT AND THE CONNECTOR WERE RETURNED AND CONFIRMED TO BE BROKEN. THE SALES REPRESENTATIVE WAS CONTACTED AND INFORMED ALPHATEC SPINE THAT THE PT HAS NOT ACHIEVED FUSION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. THERE WERE MULTIPLE PARTS AND LOT NUMBERS INVOLVED ON THE REPORTED INCIDENT AND THEY ARE LISTED BELOW: LN: 606293D; PN: 81102, LN: 618731; PN: 81075-380, LN: 610568D; PN: 81009, LN: 611889C; PN: 81007, LN: 604653; PN: 81009-15, LN: 610930A. THE DEVICE HISTORY RECORDS FOR THE LOTS MENTIONED ABOVE WERE EVALUATED AND DO NOT HAVE ANY QUALITY CONCERNS. THE DEVICE MASTER RECORDS FOR THE PARTS IN QUESTIONS WERE EVALUATED AND THE CHANGES MADE HAVE NO IMPACT ON THE SAFETY AND EFFECTIVENESS OF THE PRODUCT. THE CURRENT REVISION OF PART NUMBER 81007 IS STILL INITIAL RELEASE. THERE ARE NO CHANGES MADE TO PART 81007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROC ROC LUMBAR PLATING SYSTEM KWP ALPHATEC SPINE INC. 81070-840 606369D

    Patients

    Seq Age Sex Outcome Treatment
    1