BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM CANNULATED SCREW LONG THREAD/46MM

    MDR report key: 2872386 · Received December 13, 2012

    Report

    Report Number
    1719045-2012-01356
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K963192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. IMPLANTED APPROXIMATELY 2010. 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.

    Additional Manufacturer Narrative · 1

    DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. NO CONCOMITANT DEVICES USED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH PLATE AND SCREWS IN APPROXIMATELY 2010. PATIENT WAS GOING IN THE MILITARY AND REQUESTED REMOVAL. PATIENT RETURNED TO O.R. ON (B)(6) 2012 FOR REMOVAL OF HARDWARE. DURING THE REMOVAL TWO SCREWS STRIPPED AND ONE SCREW BROKE. SURGEON CORED AROUND THE SCREWS TO REMOVE THEM. SURGEON X-RAYED THE SITE AND NO FRAGMENTS OF HARDWARE REMAIN. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.0MM CANNULATED SCREW LONG THREAD/46MM CANNULATED SCREW HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention PLATE, SCREW