BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP SUPERIOR CLAVICLE PLATE/8 HOLE/LEFT/115MM

    MDR report key: 2193339 · Received July 29, 2011

    Report

    Report Number
    3003506883-2011-00507
    Event Type
    Injury
    Date Received
    July 29, 2011
    Report Date
    July 1, 2011
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED. A DEVICE HISTORY RECORD REVIEW WILL BE REQUESTED.

    Description of Event or Problem · 1

    PATIENT STATUS POST IMPLANTATION WITH A 3.5MM LCP SUPERIOR CLAVICLE PLATE ON (B)(6) 2011, RETURNED TO THE OPERATING ROOM FOR REVISION ON (B)(6) 2011. REPORTEDLY THE PATIENT WAS ON A LADDER AND FELL WHICH CAUSED THE CLAVICLE PLATE TO COME OFF THE BONE. THE PLATE AND THE SCREWS BACKED OFF THE BONE ON THE LATERAL SIDE. PATIENT WAS REVISED TO A 3.5MM LCP SUPERIOR CLAVICLE PLATE WITH LATERAL EXTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM LCP SUPERIOR CLAVICLE PLATE/8 HOLE/LEFT/115MM :LCP SUPERIOR CLAVICLE PLATE HRS SYNTHES ELMIRA 6245819

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention SCREW