BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM/3.5MM VA-LCP OLECRANON PL 2H/LT/90MM

    MDR report key: 2896961 · Received January 4, 2013

    Report

    Report Number
    3003506883-2013-00004
    Event Type
    Injury
    Date Received
    January 4, 2013
    Report Date
    December 7, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K120070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 VA PROXIMAL OLECRANON PLATE AND SCREW CONSTRUCT ON (B)(6) 2012 TO TREAT A FRACTURE ELBOW. POST OPERATIVELY AND POST DISCHARGE FROM THE HOSPITAL, THE PATIENT FELL IN THE SHOWER AND LANDED ON THEIR ELBOW. UPON EXAMINATION AND X-RAY ON AN UNKNOWN DATE, IT WAS REVEALED THAT ONE OF THE VA LOCKING SCREWS HAD PULLED OUT OF THE PLATE WHEN THE PATIENT FELL, LOOSENING THE ENTIRE CONSTRUCT. THE PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2012. THE SURGEON REMOVED ALL THE HARDWARE. DUE TO ADDITIONAL DAMAGE TO THE ORIGINAL FRACTURE SITE, THE SURGEON DECIDED NOT TO RE-IMPLANT ADDITIONAL HARDWARE. THERE WAS NO ADDITIONAL INFORMATION ON THE CONDITION OF THE PATIENT FOLLOWING THE REMOVAL. THIS IS 1 OF 6 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4666 2.7MM/3.5MM VA-LCP OLECRANON PL 2H/LT/90MM PLATE HRS SYNTHES ELMIRA 6980373

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention SCREWS