BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATE

    MDR report key: 1921613 · Received December 6, 2010

    Report

    Report Number
    3003506883-2010-00063
    Event Type
    Injury
    Date Received
    December 6, 2010
    Report Date
    November 11, 2010
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K082625
    Removal / Correction Number
    Z-0309-2010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. SYNTHES IS UNABLE TO PROVIDE THE DATE OF MANUFACTURE AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. WITHOUT A LOT NUMBER, A DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. THIS WAS THE SUBJECT OF A MEDICAL DEVICE RECALL; HOWEVER, THE INFORMATION DOES NOT REASONABLY SUGGEST ASSOCIATION WITH THIS EVENT.

    Description of Event or Problem · 1

    PATIENT STATUS POST PROXIMAL HUMERUS PLATE AND PROXIMAL LOCKING SCREWS IMPLANTATION EXPERIENCED A FALL. PATIENT RETURNED TO SURGEON AND AN X-RAY SHOWED FIVE PROXIMAL LOCKING SCREWS HAVE BACKED OUT OF THE PLATE, THE SCREWS DID NOT GO THROUGH THE PLATE. SURGEON EXPLANTED THE HARDWARE AND REVISED THE PATIENT TO EPOCA SYSTEM. THIS IS TWO OF SIX REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATE LCP PROXIMAL HUMERUS PLATES HRS SYNTHES ELMIRA NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention SCREWS