BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM FIXED ANGLED SELF-TAPPING SCREW, 16MM

    MDR report key: 1662366 · Received April 15, 2010

    Report

    Report Number
    2027467-2010-00008
    Event Type
    Injury
    Date Received
    April 15, 2010
    Date of Event
    March 24, 2010
    Report Date
    March 24, 2010
    Manufacturer
    ALPHATEC SPINE INC.
    Product Code
    KWQ
    PMA / PMN Number
    K070681
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY: (B) (6). SUSPECT DEVICES HAVE NOT BEEN RETURNED. ON-SITE INVESTIGATION WAS PERFORMED WHICH CONCLUDED THAT THE RECOMMENDED SCREW PLACEMENT AND/OR POSITION AS STATED IN THE SUPPLIED IFU, APPEARED NOT TO HAVE BEEN FOLLOWED. BOTH THE SURGICAL TECHNIQUE AND THE IFU STATE; THE SURGEON MUST TAKE GREAT CARE TO PROPERLY POSITION BONE SCREW HOLES WHEN USING THE VARIABLE DRILL GUIDE AND SELF CENTERING AWL. EXCESSIVELY CONVERGING OR DIVERGING SCREW PLACEMENT MAY PROHIBIT PROPER SEATING OF THE BONE SCREWS. SCREWS ANGLED BEYOND 9 DEGREES CEPHALAD TO CAUDAL AND/OR 7 DEGREES MEDIAL TO LATERAL MAY PROHIBIT PROPER SEATING. THE LOT NUMBERS OF THE ALLEGED MALFUNCTIONED DEVICES HAVE NOT BEEN PROVIDED. DEVICE 2: MODEL # 61340-016, CATALOG # 61340-016.

    Description of Event or Problem · 1

    DEVICE 1: ON (B) (6) 2009 - AFTER PREVIOUS FUSION FAILED TO OCCUR USING COMPETITIVE PRODUCTS, DOCTOR PERFORMED A SURGICAL INTERVENTION TO FUSE C5-C7 USING THE TRESTLE PLATING SYSTEM. ON (B) (6) 2010 - DURING PATIENT FOLLOW-UP, IT WAS REPORTED THAT FUSION AGAIN FAILED AT C5-C7 AND SURGICAL INTERVENTION WAS PERFORMED TO REMOVE MULTIPLE SCREWS. NEW TRESTLE SCREWS WERE PLACED TO SECURE THE INSTRUMENTATION. NO IRREGULARITIES WERE REPORTED AT THE TIME OF THE SECOND SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.0MM FIXED ANGLED SELF-TAPPING SCREW, 16MM KWQ ALPHATEC SPINE INC. 61540-016 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention