BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARIABLE ANGLE SELF-TAPPING SCREW, 4.0MM X 14MM, TI

    MDR report key: 3132197 · Received May 29, 2013

    Report

    Report Number
    2027467-2013-00013
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 9, 2013
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    KWQ
    PMA / PMN Number
    K070681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO EVALUATION POSSIBLE. THE SUSPECT DEVICE REMAINS SECURELY ANCHORED WITHIN THE PATIENTS VERTEBRAL BODY (C5). THE SURGEON INDICATED REVISION SURGERY IS NOT REQUIRED DUE TO COMPLETE FUSION AND HEALING. INSTRUCTIONS FOR USE (INS-014) PROVIDES INFORMATION TO AID IN REDUCING THIS TYPE OF EVENT. POSTOPERATIVE MANAGEMENT: 7. 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. THE TRESTLE ANTERIOR CERVICAL PLATING SYSTEM IS A TEMPORARY DEVICE USED TO STABILIZE THE CERVICAL SPINE DURING BONE FUSION DEVELOPMENT. DEVICE IMPLANTS INCLUDE A RANGE OF PLATE SIZES AND BONE SCREWS TO PROVIDE THE VERSATILITY REQUIRED FOR THE SPECIFIC INDICATIONS NOTED. FIXATION IS ACHIEVED BY MEANS OF A RIGID PLATE THAT IS SURGICALLY ATTACHED TO THE SPINE WITH BONE SCREWS. IMPLANT PLATES ARE MANUFACTURED FROM SURGICAL GRADE TITANIUM ALLOY (B)(4) AND NITINOL (B)(4) AND THE BONE SCREWS ARE MANUFACTURED FROM SURGICAL GRADE TITANIUM ALLOY (B)(4). ALL DEVICE COMPONENTS ARE INTENDED FOR FIXATION/ATTACHMENT TO THE ANTERIOR CERVICAL SPINE ONLY. IT IS INTENDED THAT THE IMPLANTS BE REMOVED AFTER SUCCESSFUL FUSION.

    Additional Manufacturer Narrative · 1

    INITIAL PRODUCT DESCRIPTION AND PART NUMBER PROVIDED BY COMPLAINANT WAS INCORRECT. UPDATED INFORMATION RECEIVED 6/11/2013.

    Description of Event or Problem · 1

    POST-OP X-RAYS TO CONFIRM FUSION HAD OCCURRED ALSO DISCOVERED A BROKEN TRESTLE SELF DRILLING SCREW. THE FRACTURED OCCURRED APPROXIMATELY MID-WAY OF THE THREADED SHAFT AND REMAINS SECURELY ANCHORED WITHIN THE C5 VERTEBRAL BODY. THE SURGEON INDICATED REVISION SURGERY WAS NOT NECESSARY. FUSION WAS SUCCESSFUL AND THE (B)(6) YEAR OLD PATIENT HAS COMPLETELY HEALED. THE TRESTLE ANTERIOR CERVICAL PLATING SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237101 VARIABLE ANGLE SELF-TAPPING SCREW, 4.0MM X 14MM, TI KWQ KWQ ALPHATEC SPINE INC 61340-014

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other