BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIX 5.5 GRAPHIC CASE F/POLYAXIAL SCRE

    MDR report key: 2861830 · Received December 7, 2012

    Report

    Report Number
    3003787298-2012-00019
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 8, 2012
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE STERILIZING FACILITY HAS BEEN PROVIDED WITH SYNTHES GUIDELINES FOR THE CARE AND MAINTENANCE OF IMPLANTS, INSTRUMENTS & CASES. NOTABLY, THE PH LEVEL USED IN THEIR STERILIZING FACILITY IS 10. ACCORDING TO THE GUIDELINES THIS FALLS OUTSIDE OF THE RECOMMENDED 6-9.5 PH RANGE FOR DEALING WITH ALUMINUM. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. NOTE: THIS DEVICE IS USED FOR TREATMENT.

    Description of Event or Problem · 1

    THE HOSPITALS STERILIZING FACILITY HAS REPORTED THAT THEY HAVE CONSISTENTLY IDENTIFIED STAINING ON THE INSIDE OF THE KIMGUARD WRAPPING AROUND THE MATRIX DEGENERATIVE TRAYS SUBSEQUENT TO STERILIZING. THE DARK STAINS ON THE WRAPPING APPEAR MOST PROMINENT ON KIMGUARD USED TO WRAP TRAYS THAT HOUSE THE SCREWS OR OTHER IMPLANTS. THE STAINS ARE SUSPECTED TO COME FROM THE BLACK ALUMINUM MATERIAL THAT MAKE UP THE VARIOUS IMPLANT CADDIES. THESE OBSERVATIONS WERE MADE DURING THE VALIDATION PROCESS THAT THE STERILIZING FACILITY CONDUCTS TO ENSURE THAT SETS USED MEET THEIR STERILITY GUIDELINES. THIS IS THE 2ND OF 2 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX 5.5 GRAPHIC CASE F/POLYAXIAL SCRE MATRIX 5.5 GRAPHIC CASE LXH SYNTHES JENNERSVILLE

    Patients

    Seq Age Sex Outcome Treatment
    1