BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI STANDARD PEDICLE BOLT

    MDR report key: 2220494 · Received August 23, 2011

    Report

    Report Number
    2027467-2011-00017
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 3, 2011
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    MNH
    PMA / PMN Number
    K050078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION CANNOT BE CONDUCTED. THE BROKEN TITANIUM BOLT REMAINS ANCHORED IN THE PATIENT WHERE ORIGINALLY POSITIONED. THE CORE LUMBAR FIXATION SYSTEM FACILITATES THE SURGICAL CORRECTION OF SPINAL DEFORMITIES BY PROVIDING TEMPORARY INTERNAL FIXATION AND STABILIZATION DURING BONE GRAFT HEALING AND/OR FUSION MASS DEVELOPMENT. THE IMPLANTS ARE MANUFACTURED (B)(4). IT IS INTENDED THAT THE IMPLANTS BE REMOVED AFTER SUCCESSFUL FUSION. ALL IMPLANTS ARE INTENDED FOR SINGLE USE ONLY AND SHOULD NOT BE REUSED UNDER ANY CIRCUMSTANCES. THE SUPPLIED IFU (INS-011) STATES IN THE WARNINGS AND PRECAUTIONS SECTION; BASED ON FATIGUE TESTING RESULTS FROM THESE SYSTEMS ARE SIGNIFICANTLY AFFECTED BY THE SURGEON'S PROPER PATIENT SELECTION, PREOPERATIVE PLANNING, PROPER SURGICAL TECHNIQUE, PROPER SELECTION AND PLACEMENT OF IMPLANTS, PROPER REDUCTION AND COMPLETE COMPLIANCE OF THE PATIENT. THE SELECTION OF THE PROPER SIZE, SHAPE AND DESIGN OF THE IMPLANT FOR EACH PATIENT IS CRUCIAL TO THE SUCCESS OF THE PROCEDURE. METAL IMPLANTS ARE SUBJECT TO REPEATED STRESSES IN USE, AND THEIR STRENGTH IS LIMITED BY THE NEED TO ADAPT THE DESIGN TO THE SIZE AND SHAPE OF HUMAN BONES. UNLESS GREAT CARE IS TAKEN IN PATIENT SELECTION, PROPER PLACEMENT OF THE IMPLANT, AND POSTOPERATIVE MANAGEMENT TO MINIMIZE STRESSES ON THE IMPLANT, SUCH STRESSES MAY CAUSE METAL FATIGUE AND CONSEQUENT BREAKAGE, BENDING, OR LOOSENING OF THE DEVICE BEFORE THE HEALING PROCESS IS COMPLETE, WHICH MAY RESULT IN FURTHER INJURY OR THE NEED TO REMOVE THE DEVICE PREMATURELY. POTENTIAL RISKS IDENTIFIED WITH THE USE OF THESE DEVICES, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE DEVICE COMPONENT FRACTURE, LOSS OF FIXATION, NON-UNION, FRACTURE OF THE VERTEBRA, NEUROLOGICAL INJURY, VASCULAR OR VISCERAL INJURY. UPON RECEIPT OF UPDATED AND/OR ADDITIONAL INFORMATION A FOLLOW-UP SUBMISSION WILL BE PROVIDED.

    Description of Event or Problem · 1

    A BROKEN PEDICLE BOLT WAS DISCOVERED DURING A POST-OP VISIT ON (B)(6) 2011. X-RAYS REVEALED THE TITANIUM BOLT HAD FRACTURED AND BROKE APPROXIMATELY 1/3 OF THE WAY DOWN FROM THE PROXIMAL HEAD. REVISION SURGERY HAS NOT BEEN DECIDED. THE CORE LUMBAR FIXATION SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI STANDARD PEDICLE BOLT MNH, MNI MNH ALPHATEC SPINE INC 81285-380 624029

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other