BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI, ILIAC BONE SCREW

    MDR report key: 3132752 · Received May 29, 2013

    Report

    Report Number
    2027467-2013-00011
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 19, 2013
    Report Date
    May 2, 2013
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    MNI
    PMA / PMN Number
    K081158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS NOT POSSIBLE AT THIS TIME. THE SUSPECT DEVICE HAS NOT BEEN REMOVED FROM THE PATIENT. THE IDENTIFYING PRODUCT PART NUMBER AND/OR LOT NUMBER HAS NOT BEEN PROVIDED. UPON THE RECEIPT OF ADDITIONAL INFORMATION OR THE DEVICE IN QUESTION A FOLLOW UP REPORT WILL BE SUBMITTED. THE ILLICO MIS POSTERIOR FIXATION SYSTEM IS INTENDED TO FACILITATE THE SURGICAL CORRECTION OF NONCERVICAL SPINAL DEFORMITIES BY PROVIDING TEMPORARY INTERNAL FIXATION AND STABILIZATION DURING BONE GRAFT HEALING AND/OR FUSION MASS DEVELOPMENT. WHEN USED FOR A MINIMALLY INVASIVE POSTERIOR APPROACH ILLICO MIS INSTRUMENTATION IS USED IN CONJUNCTION WITH POLYAXIAL SCREW COMPONENTS. THE IMPLANTS ARE MANUFACTURED FROM SURGICAL GRADE TITANIUM ALLOY (TI-6AL-4V ELI OR TI-6AL-4V). THE RODS ARE AVAILABLE IN COMMERCIALLY PURE (CP) TITANIUM AND/OR COBALT CHROME.

    Additional Manufacturer Narrative · 1

    AN OPERATIVE REPORT RECENTLY RECEIVED BY ALPHATEC PROVIDED BOTH CORRECTED AND ADDITIONAL INFORMATION. CORRECTED INFORMATION - SEX: FEMALE. DESCRIPTION OF EVENT: X-RAYS TAKEN DURING AN (B)(6) 2013 FOLLOW-UP VISIT DISCOVERED A BROKEN ILIAC BONE SCREW LOCATED IN THE PATIENTS SACROILIAC JOINT. THE SUPPLIED IMAGES INDICATED THE SCREW FRACTURED APPROXIMATELY MID-WAY OF THE THREADED SHAFT AND REMAINS SECURELY ANCHORED WITHIN THE CONSTRUCT. BRAND NAME: TI, ILIAC BONE SCREW. (B)(4). ADDITIONAL INFORMATION - THE ZODIAC DEFORMITY IMPLANTS WERE INSTALLED ON (B)(6) 2012 DURING A REVISION SURGERY FOR AN UNRELATED ISSUE (LOOSENING OF HARDWARE). AT THE TIME OF THE SECOND OPERATION, THE SURGEON PERFORMED AN ANTERIOR L5-S1 DISKECTOMY AND FUSION, AND REMOVAL OF AN OLD L5-S1 CAGE. IT WAS REPLACED WITH A STRUCTURAL ALLOGRAFT WITH AN INTERFERENCE SCREW. X-RAYS WHICH DISCOVERED THE FRACTURED SCREW WITHIN THE SACROILIAC JOINT ALSO CONFIRMED SOLID FUSION FROM L2-S1. THE SURGEON EXPLAINED TO THE PATIENT THAT NEITHER THE PROXIMAL NOR THE DISTAL SECTIONS OF THE FRACTURED SCREW WILL BE MOVING. THE SURGEON IS CERTAIN THAT THE FRACTURE IS A RESULT OF NORMAL MOTION ACROSS HER SACROILIAC JOINT. IT IS UNCOMMON, BUT IN THIS CASE, THE FUSION IS COMPLETELY SOLID, SO THERE WILL BE NO ILL EFFECTS FROM THIS. THE ZODIAC POLYAXIAL SPINAL 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 FROM SURGICAL GRADE TITANIUM ALLOY ((B)(4) OR (B)(4)) OR STAINLESS STEEL. IMPLANT RODS ARE ALSO AVAILABLE IN COMMERCIALLY PURE TITANIUM (TI GRADE 4) AND COBALT CHROME (COCR). ALL HOOKS ARE INTENDED FOR FIXATION/ATTACHMENT TO THE POSTERIOR THORACIC AND LUMBAR SPINE ONLY. IT IS INTENDED THAT THE IMPLANTS BE REMOVED AFTER SUCCESSFUL FUSION. THE SUPPLIED INSTRUCTION FOR USE ((B)(4)) PROVIDED INFORMATION TO AID IN PREVENTING THIS TYPE OF OCCURRENCE. POSTOPERATIVE MANAGEMENT: THE ZODIAC POLYAXIAL SPINAL FIXATION 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

    X-RAYS TAKEN DURING AN (B)(6) 2013 FOLLOW-UP VISIT DISCOVERED A BROKEN CANNULATED POLYAXIAL SCREWS LOCATED IN THE PATIENTS SACRUM. THE SUPPLIED IMAGES INDICATED THE SCREW FRACTURED APPROXIMATELY MID-WAY OF THE THREADED SHAFT AND REMAINS SECURELY ANCHORED WITHIN THE CONSTRUCT. THE DATE THE ILLICO FIXATION SYSTEM WAS ORIGINALLY IMPLANTED HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236917 TI, ILIAC BONE SCREW MNI, KWP, MNH MNI ALPHATEC SPINE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other