BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM VARIABLE ANGLED SELF-TAPPING SCREW, 16MM

    MDR report key: 1762167 · Received May 26, 2010

    Report

    Report Number
    2027467-2010-00010
    Event Type
    Injury
    Date Received
    May 26, 2010
    Date of Event
    May 12, 2010
    Report Date
    May 14, 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

    REVISION SURGERY WILL BE REQUIRED TO REMOVE BOTH BROKEN SCREWS. THE DATE HAS NOT YET BEEN SCHEDULED. EVALUATION NOT POSSIBLE. SUSPECT DEVICE HAS NOT BEEN RETURNED. THE SUPPLIED IFU STATE, IN POSTOPERATIVE MANAGEMENT #(B)(4); THE TRESTLE ANTERIOR CERVICAL PLATING SYSTEM IMPLANTS ARE DESIGNED AND INTENDED AS TEMPORARY FIXATION DEVICES. THE DEVICES SHOULD BE REMOVED AFTER COMPLETE HEALING HAS OCCURRED. DEVICES WHICH ARE NOT REMOVED AFTER SERVING THEIR INTENDED PURPOSE MAY BEND, DISLOCATE OR BREAK AND/OR CAUSE CORROSION, LOCALIZED TISSUE REACTION, PAIN, INFECTION AND/OR BONE LOSS DUE TO STRESS SHIELDING. COMPLETE POSTOPERATIVE MANAGEMENT TO MAINTAIN THE DESIRED RESULT SHOULD ALSO FOLLOW IMPLANT REMOVAL SURGERY.

    Description of Event or Problem · 1

    ON (B)(6)2006 - ORIGINAL SURGERY IN WHICH COMPETITIVE PRODUCTS WERE IMPLANTED IN THE C45, C56, & C67 LOCATIONS. ON (B)(6)2009 - PT RETURNS TO OPERATING ROOM. THE SURGEON PERFORMED ANTERIOR CERVICAL DISCECTOMY FUSION AT THE C56, C67 & C7T1 USING THE TRESTLE PLATING SYSTEM. NO IRREGULARITIES WERE REPORTED AT THE TIME OF THE SURGERY. ON (B)(6)2010 - SURGEON REPORTED THAT THE PT WAS LYING IN BED, TURNED HIS NECK AND HEARD A POP. A SCAN/X-RAY REVEALED TO THE SURGEON THAT TWO SCREWS HAD BEEN BROKEN AT THE C5 LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.0MM VARIABLE ANGLED SELF-TAPPING SCREW, 16MM KWQ ALPHATEC SPINE, INC. 61340-016 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention