BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2840353 · Received November 20, 2012

    Report

    Report Number
    2520274-2012-03274
    Event Type
    Injury
    Date Received
    November 20, 2012
    Report Date
    October 24, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE:NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. DEVICE USED FOR TREATMENT.WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. (B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    DURING AN (B)(6), DATE UNKNOWN, SURGEON REPORTED TO A SENIOR PRODUCT MANAGER FROM SYNTHES: SURGEON USED SYNFIX LR AND THE PATIENT HAD LYTIC SPONDY GRADE 2-3, IMPLANT DATE UNKNOWN. IT WAS MENTIONED TO THE SURGEON BY THE SYNTHES MANAGER IT WAS AN OFF LABEL USE FOR THE PRODUCT. SURGEON WAS AWARE OF THE OFF LABEL USE AND THE OUT COME WAS A SACRAL FRACTURE. PATIENT WAS RETURNED TO OR, DATE UNKNOWN, SURGEON ADDED PEDICLE SCREWS TO STABILIZE, PROCEDURE WAS NOT PERFORMED ANTERIORLY. THIS WAS PERFORMED THE WEEK BEFORE THE CONFERENCE. THE SYNFIX REMAINS IMPLANTED, SURGEON COMMENTED: THE BONE FAILED NOT THE DEVICE. THIS IS 4 OF 5 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SYNFIX IMPLANT, SCREWS