BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNAMIC COMPRESSION CABLE PLATE SS 9 HOLE

    MDR report key: 1770944 · Received July 27, 2010

    Report

    Report Number
    1825034-2010-00288
    Event Type
    Injury
    Date Received
    July 27, 2010
    Report Date
    June 30, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDQ
    PMA / PMN Number
    K982545
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. DATE OF EVENT - UNKNOWN.DATE IMPLANTED - APPROXIMATELY ONE MONTH AGO; EXACT DATE UNKNOWN.DATE EXPLANTED - UNKNOWN.(B) (4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE UTILIZING A COMPRESSION CABLE PLATE. APPROXIMATELY ONE MONTH LATER, THE PATIENT BEGAN TO EXPERIENCE PAIN. RADIOGRAPHS TAKEN REVEALED TORSION OF THE PLATE, AND A REVISION PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE CABLE PLATE. NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNAMIC COMPRESSION CABLE PLATE SS 9 HOLE CERCLAGE, FIXATION JDQ BIOMET ORTHOPEDICS N/A 590210

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R