BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2891839 · Received December 31, 2012

    Report

    Report Number
    2520274-2012-04412
    Event Type
    Injury
    Date Received
    December 31, 2012
    Report Date
    December 3, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH OLECRANON PLATE AND TEN (10) SCREWS ON UNKNOWN DATE. PATIENT PRESENTED TO THE SURGEON WITH INFECTION. X-RAY TAKEN ON AN UNKNOWN DATE REVEALED ONE OF THE SCREWS HAD BACKED OUT. IMAGE ALSO REVEALED NON-UNION. PATIENT WAS RETURNED TO OPERATING ROOM ON (B)(6) 2012 FOR REMOVAL OF ALL HARDWARE. WHEN PATIENT INFECTION HAS CLEARED, SURGEON WILL REPLATE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS 9 OF 11 REPORTS FOR THE SAME EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention PLATE, SCREWS