BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI 8.5 MM POLYAXIAL SCREW ASSY, 45 MM (TI-6AI-4V ELI)

    MDR report key: 5998069 · Received October 4, 2016

    Report

    Report Number
    2027467-2016-00076
    Event Type
    Injury
    Date Received
    October 4, 2016
    Date of Event
    August 22, 2016
    Report Date
    September 7, 2016
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    KWP
    UDI-DI
    00844856003248
    PMA / PMN Number
    K042673
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SECOND POLYAXIAL SCREW REPORTED IS OF THE SAME PRODUCT PART NUMBER BUT CONTAINS A SEPARATE MANUFACTURING LOT NUMBER ; A 692540 MANUFACTURED 6/1/2015. AN EVALUATION IS NOT POSSIBLE AT THIS TIME. THE USER FACILITY HAS NOT RETURNED THE PROXIMAL SECTIONS OF THE EXPLANTED POLYAXIAL SCREWS TO THE INTERNATIONAL DISTRIBUTOR. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO MANUFACTURING, PROCESSING OR DESIGN RELATED IRREGULARITIES. THE RECORDS INDICATE THE IMPLANTS WERE PROPERLY MANUFACTURED AND RELEASED IN ACCORDANCE WITH DESIGN SPECIFICATIONS. UPON THE RECEIPT OF ADDITIONAL INFORMATION AND/OR THE IMPLANTS IN QUESTION, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    POST OP X-RAYS TAKEN (B)(6) 2016 REVEALED TWO (2) POLYAXIAL SCREWS LOCATED AT L5 HAD FRACTURED AND BROKE. REVISION SURGERY WAS CONDUCTED (B)(6) 2016 TO REMOVE AND REPLACE THE ZODIAC CONSTRUCT. THE PROXIMAL SECTIONS OF BOTH SCREWS WERE REMOVED WITHOUT ISSUE, WHILE THE DISTAL THREADED PORTIONS REMAIN ENTRAPPED WITHIN THE RIGHT & LEFT SIDE OF THE PATIENTS L5. THE ZODIAC DEGENERATIVE SPINAL FIXATION SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2015 FROM THE L3 TO L5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648638 TI 8.5 MM POLYAXIAL SCREW ASSY, 45 MM (TI-6AI-4V ELI) PEDICLE SCREW SPINAL FIXATION KWP ALPHATEC SPINE INC 62085-45 683893 00844856003248

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization