BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANNULATED POLYAXIAL SCREW 6.5MM X 45MM, TI

    MDR report key: 2872845 · Received December 13, 2012

    Report

    Report Number
    2027467-2012-00031
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    October 11, 2012
    Report Date
    November 29, 2012
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    KWP
    PMA / PMN Number
    K042673
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE SUSPECT DEVICE FOUND THE IMPLANT WAS PROPERLY MANUFACTURED AND RELEASED TO DESIGN SPECIFICATIONS. NO IRREGULARITIES HAVE BEEN IDENTIFIED. THE COMPLIANT RECEIVED STATED THAT X-RAYS IDENTIFIED CONSIDERABLE DISTORTION OF THE PEDICLE SCREW WHICH COULD BE THE BENDING OF THE SCREW THROUGH THE SHANK. X-RAYS AND INFORMATION WHETHER A FUSION HAD OCCURRED WAS NOT AVAILABLE. SINCE THE REVISION SURGERY TOOK PLACE 2 YEARS IT IS ASSUMED THAT A SUCCESSFUL FUSION HAD NOT OCCURRED AND THIS COULD BE A RESULT OF THE BENDING OF THE SCREWS DUE TO CONTINUOUS LOADING ON THE SCREWS (INFORMATION ON THE PATIENT BONE QUALITY DURING SURGERY IS NOT PROVIDED). ILLICO SCREWS ARE INDICATED PER THE ILLICO INSTRUCTIONS FOR USE ((B)(4)) FOR TEMPORARY INTERNAL FIXATION AND STABILIZATION DURING BONE GRAFT HEALING AND/OR FUSION MASS DEVELOPMENT. SCREW FAILURE OCCURRED IN THE REVISION SURGERY DURING EXTRACTION IN THE THREAD TAPER REGION, WHICH IS DESIGNED TO INCREASE WEDGING AND COMPACTION OF THE BONE DURING INSERTION, PROVIDING MORE SECURE FIXATION. DURING REVISION SURGERY, ADDITIONAL FORCES WERE TRANSFERRED AT THE DISTAL TIP OF THE SCREW FOR REMOVAL OF THE SCREW AND RESULTED IN THE BROKEN SCREW. THE SCREW APPEARS TO BE MANUFACTURED CORRECTLY AND THE DESIGN APPEARS TO BE APPROPRIATE BASED ON THE SIMILARITY TO EXISTING SYSTEMS (ZODIAC) AND THE EVIDENCE OF ONLY A FEW ISOLATED ISSUES OUT OF A LARGE NUMBER OF CASES. THUS UNKNOWN CLINICAL FACTORS/CIRCUMSTANCES RELATED TO EITHER THE PATIENT OR PROCEDURE CAUSED THE SCREWS TO FAIL (COMPLETE DETAILS ATTACHED). THE SUPPLIED INSTRUCTIONS FOR USE ((B)(4)) PROVIDE A WARNING TO AID IN REDUCING THIS TYPE OF EVENT. WARNINGS: THE ILLICO MIS POSTERIOR FIXATION SYSTEM IMPLANTS ARE USED ONLY TO PROVIDE TEMPORARY INTERNAL FIXATION DURING THE BONE FUSION PROCESS WITH THE ASSISTANCE OF A BONE GRAFT. A SUCCESSFUL RESULT MAY NOT BE ACHIEVED IN EVERY INSTANCE OF USE WITH THESE DEVICES. WITHOUT SOLID BONE FUSION, THESE DEVICES CANNOT BE EXPECTED TO SUPPORT THE SPINE INDEFINITELY AND MAY FAIL DUE TO BONE-METAL INTERFACE, ROD FAILURE OR BONE FAILURE. 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 ((B)(4)). THE RODS ARE AVAILABLE IN (B)(4).

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN RETURNED BY THE INTERNATIONAL CUSTOMER AND IS CURRENTLY BEING EVALUATED. A FOLLOW-UP REPORTED WITH RESULTS OF THE INVESTIGATION WILL BE SUBMITTED UPON COMPLETION.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE SCREW WAS PROPERLY MANUFACTURED AND RELEASED TO DESIGN SPECIFICATION. NO IRREGULARITIES WERE IDENTIFIED. THE PROXIMAL SECTION OF THE SUSPECT DEVICE IS IN ROUTE FROM THE INTERNATIONAL CUSTOMER. UPON RECEIPT THE IMPLANT WILL BE EVALUATED AND A FOLLOW-UP SUBMISSION PROVIDED.

    Description of Event or Problem · 1

    AN INTERNATIONAL CUSTOMER ((B)(6)) REPORTED THAT A PATIENT EXPRESSED HE HAD BEEN ENCOUNTERING SOME DISCOMFORT. X-RAYS IDENTIFIED CONSIDERABLE DISTORTION OF A PEDICLE SCREW. REVISION SURGERY TOOK PLACE ON (B)(6) 2012, DURING WHICH THE DISTORTED SCREW FRACTURED AND BROKE WHILE EXPLANTING. THE PROXIMAL SECTION WAS REMOVED WITHOUT ISSUE WHILE THE THREADED DISTAL SECTION OF THE SHAFT REMAINS SECURED WITHIN THE PATIENTS PEDICLE. THE ILLICO MIS POSTERIOR FIXATION SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNULATED POLYAXIAL SCREW 6.5MM X 45MM, TI KWP, MNI, MNH KWP ALPHATEC SPINE INC 73865-45 636582

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention