BEUDAMED
    FDA Adverse Event Summary report: N

    ALPHATEC

    MDR report key: 520376 · Received February 26, 2004

    Report

    Report Number
    MW4003669
    Date Received
    February 26, 2004
    Report Date
    February 26, 2004
    Manufacturer
    ALPHATEC MFG INC. AKA NEXMED INC
    Product Code
    HWC
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 5/12/04: NO SPECIFIC DEVICE MODEL NUMBER AND/OR CATALOG NUMBER WAS IDENTIFIED IN THE MEDICAL DEVICE REPORT. THE ZODIAC POLYAXIAL PEDICLE SCREW SYSTEM MODEL/CATALOG NUMBERS CAN BE FOUND IN SECTION 25 OF THE PRE-MARKET APPLICATION (K033090). NO SPECIFIC LOT AND/OR SERIAL NUMBER FOR THE DEVICE WERE IDENTIFIED IN THE MEDICAL DEVICE REPORT. ZODIAC SYSTEM COMPONENTS, IDENTIFIED IN SECTION 25 OF THE PRE-MARKET APPLICATION (K033090) ARE MANUFACTURED AND DISTRIBUTED WITH FULL IDENTIFICATION AND TRACEABILITY MEASURES IN PLACE. THE ZODIAC POLYAXIAL PEDICLE SCREW SYSTEM WAS CLEARED UNDER 510(K) K033090. ALPHATEC MANUFACTURING INC HAS NO KNOWLEDGE OF ANY INCIDENTS WITH ZODIAC POLYAXIAL PEDICLE SCREW SYSTEM. NO COMPLAINTS HAVE BEEN RECEIVED. NO MEDICAL DEVICE REPORTS HAVE BEEN RECEIVED, NOR FILED BY ALPHATEC WITH THE FDA.

    Description of Event or Problem · 1

    COMPLAINANT IS REPORTING THE USE OF SURGICAL SCREW BY DR AND TWO HOSPS. USE OF THE SCREW IS NOT FDA APPROVED AS THE SCREW DOES NOT HAVE AN APPROVED 510K DEVICE REGISTRATION AT ALL. COMPLAINANT'S INFO IS THAT SCREW WAS BEING USED BY HOSPITAL AND WHEN THEY DISCOVERED IT WAS NOT APPROVED FOR ANY USE, THEY DISALLOWED ANY USE IN SURGERY IN THEIR HOSPITAL. COMPLAINANT SAID THAT THE SCREW STARTED TO BE MANUFACTURED IN DEC., 2003 AND THAT IT IS MANUFACTURED IN THE CARLSBAD LOCATION. THERE HAVE BEEN NO INJURIES ASSOCIATED WITH THE USE OF THIS SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHATEC ZODIAC SCREW HWC ALPHATEC MFG INC. AKA NEXMED INC * NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *