BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROSCREW 9 X 20 MM

    MDR report key: 665015 · Received January 17, 2006

    Report

    Report Number
    1220246-2005-00247
    Event Type
    Injury
    Date Received
    January 17, 2006
    Date of Event
    April 7, 2005
    Report Date
    January 10, 2006
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT AN ACL REPAIR IN 2004 WITH THREE DIFFERENT IMPLANTS. IN 2005, APPROXIMATELY 1YR 1MO POST-OP, THE PATIENT HAD A SECOND SURGERY TO REMOVE PIECES OF THE RETROSCREW IN THE JOINT. EVENT WAS INITIALLY REPORTED TO ARTHREX INC IN 12/2005 BUT SPECIFIC DETAILS SUCH AS THE PART NUMBER WERE NOT OBTAINED UNTIL EIGHT DAYS LATER. THIS DEVICE IS USED FOR TREATMENT.

    Description of Event or Problem · 1

    PT UNDERWENT AN ACL REPAIR ON 03/08/04 WITH THREE DIFFERENT IMPLANTS. ON 04/07/05, APPROX 1YR 1M POST-OP, THE PT HAD A SECOND SURGERY TO REMOVE PIECES OF THE RETROSCREW IN THE JOINT SPACE. EVENT WAS INITIALLY REPORTED TO ARTHREX INC. ON 12/05/2005 BUT SPECIFIC DETAILS SUCH AS THE PART NUMBER WERE NOT OBTAINED UNTIL 12/23/05. IT WAS ALSO REPORTED THAT THE SURGEON STATED THE HEAD OF THE RETROSCREW SHOWED MORE DEGRADATION THAN THE BODY. TWO OF THE ORIGINAL IMPLANTS AND PIECES OF THE RETROSCREW REMOVED FROM THE PT WERE RETURNED. NO CONCERNS WERE REPORTED WITH THE FIRST TWO IMPLANTS. THIS DEVICE IS USED FOR TREATMENT. 4

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETROSCREW 9 X 20 MM BIO-ABSORBABLE IMPLANT MAI ARTHREX, INC. AR-1586RB-09 38220

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention