BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLECRANON OSTEOTOMY NAIL

    MDR report key: 3062335 · Received April 16, 2013

    Report

    Report Number
    8030965-2013-01700
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    March 21, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    PMA / PMN Number
    K073402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    HEALTH 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. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT WITH LEFT DISTAL HUMERUS FRACTURE WITH OLECRANON OSTEOTOMY WAS IMPLANTED WITH OLECRANON NAIL, END CAP, TWO SCREWS AND A HUMERAL PLATE AND SCREWS ON (B)(6) 2013. ON AN UNKNOWN POST-OPERATIVE DATE, X-RAYS REVEALED THAT THE NAIL END CAP LOOSENED CAUSING THE OLECRANON OSTEOTOMY TO DISPLACE. PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2013 FOR REVISION SURGERY. AT THIS TIME, END CAP WAS REMOVED, THE OSTEOTOMY SITE WAS CLEANED, NEW END CAP WAS PLACED, AND A FIVE HOLE LOCKING COMPRESSION PLATE WAS IMPLANTED FOR ROTATIONAL CONTROL. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162405 OLECRANON OSTEOTOMY NAIL HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention