BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I.T.S. CLAVICULAPLATE WITH ANGULAR STABILITY

    MDR report key: 1233504 · Received November 7, 2008

    Report

    Report Number
    3004369035-2008-00001
    Event Type
    Injury
    Date Received
    November 7, 2008
    Date of Event
    August 23, 2008
    Report Date
    September 17, 2008
    Manufacturer
    I.T.S. GMBH
    Product Code
    HRS
    PMA / PMN Number
    k050852
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FRACTURE EVAL INDICATES FATIGUE FRACTURE OF DEVICE. MEDWATCH REPORT INDICATES PHYSICIAN REPORT STATING "HE (I.E. PT) REPORTS THAT HE WAS BEING RATHER ACTIVE, AND NOTED ACUTE ONSET OF PAIN IN THE RIGHT SHOULDER". CONCLUSION: OVER ACTIVITY OF PT IN SHORT TIME PERIOD (AT 5 WEEKS) DID NOT ALLOW ADEQUATE BONE HEALING OF THE CLAVICLE BONE FRACTURE. PT REPEAT HIGH ACTIVITY STRESS ON CLAVICLE PLATE CAUSED FATIGUE FRACTURE OF PLATE.

    Description of Event or Problem · 1

    FAILED (FRACTURED) BONE PLATE (RIGHT CLAVICLE) 5 WEEKS POST-OP, AS REPORTED THROUGH MEDWATCH ON 10/14/2008. PT REPORTS IMMEDIATE ONSET OF PAIN IN SHOULDER/CLAVICLE AREA IN 2008. INTERVENTION SURGERY WAS CONDUCTED ABOUT TWO DAYS LATER, TO REMOVE FRACTURED CLAVICLE PLATE, RE-ALIGN CLAVICLE BONE, AND REPAIR WITH INSERTION OF NEW CLAVICLE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I.T.S. CLAVICULAPLATE WITH ANGULAR STABILITY HRS - PLATE, FIXATION, BONE HRS I.T.S. GMBH 21121-8 00/071203

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention