BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCHRONOS BETA-TCP STRIP 100M X 25MM X 3MM-STE

    MDR report key: 2752024 · Received September 17, 2012

    Report

    Report Number
    1719045-2012-00951
    Event Type
    Injury
    Date Received
    September 17, 2012
    Report Date
    August 21, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MQV
    PMA / PMN Number
    K071046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. STERILIZATION VALIDATION DOCUMENTATION, DECISION FINDING PROTOCOLS, DFPS, WAS REVIEWED AND DEMONSTRATED THAT EACH OF THE PART NUMBERS INCLUDED WITHIN THIS COMPLAINT HAD BEEN EVALUATED FOR STERILIZATION. THE SUPPORTING VALIDATION DEMONSTRATES THAT THE MINIMUM ROUTINE STERILIZATION DOSE EMPLOYED BY SYNTHES IS EFFECTIVE AT ACHIEVING A STERILITY ASSURANCE LEVEL (SAL) OF 10-6. THE CERTIFICATE OF PROCESSING FOR LOT N003225 WAS REVIEWED AND DEMONSTRATES THAT THE DOSE DELIVERED TO PRODUCT WAS WITHIN THE ESTABLISHED ROUTINE PRODUCTION STERILIZATION DOSE RANGE.

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH CHRONOS BETA-TCP STRIP, MATRIX SCREWS, MATRIX LOCKING CAPS, MATRIX POLYAXIAL HEADS, RODS AND T-PAL SPACER ON (B)(6) 2012 FOR A TLIF. PT LATER DEVELOPED AN INFECTION AT THE IMPLANT SITE. PT'S IMPLANTS WERE NOT REMOVED. PT WAS TREATED WITH INCISION AND DRAINAGE (I & D) AND ANTIBIOTICS BEADS AT THE INFECTION SITE. THIS IS 1 OF 22 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCHRONOS BETA-TCP STRIP 100M X 25MM X 3MM-STE CHRONOS BETA-TCP STRIP MQV SYNTHES MONUMENT N003225

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention RODS| SPACER| SCREWS| LOCKING CAPS| POLYAXIAL HEADS