BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE BLOCK H10

    MDR report key: 1644191 · Received March 29, 2010

    Report

    Report Number
    3025141-2010-00013
    Event Type
    Injury
    Date Received
    March 29, 2010
    Date of Event
    February 23, 2010
    Report Date
    March 1, 2010
    Manufacturer
    ACUMED LLC
    Product Code
    HWC
    PMA / PMN Number
    K942340
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN WHICH OF THE FOLLOWING SCREWS DESCRIBED BELOW BROKE DURING THIS EVENT AND WAS REMOVED.BRAND NAME MODEL # LOT CODE EXPIRATION DATE MANUFACTURE DATE2.3MM X 16MM LOCKING CORTICAL SCREW CO-T2316 W71038 N/A - NON STERILE 11/11/20082.3MM X 18MM LOCKING CORTICAL SCREW CO-T2318 W70512 N/A - NON STERILE 10/28/20082.3MM X 20MM LOCKING CORTICAL SCREW CO-T2320 W70430 N/A - NON STERILE 10/31/20082.3MM X 22MM LOCKING CORTICAL SCREW CO-T2322 W70431 N/A - NON STERILE 10/21/2008 2.3MM X 24MM LOCKING CORTICAL SCREW CO-T2324 W68399 N/A - NON STERILE 08/20/20082.3MM X 24MM NON-TOGGLING CORTICAL SCREW CO-N2324 W70143 N/A - NON STERILE 10/20/2008.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE DOCTOR/CUSTOMER OBSERVED A SOLUTION LEAK OUTSIDE DURING THE FILLING OF ONE INFUSOR SEVEN DAY DEVICE. THE CUSTOMER WOULD NOT DESCRIBE THE LOCATION OF THE LEAKAGE. THERE IS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    APPROXIMATELY 15 MONTHS POST PLACEMENT OF CALLOS 3CC INJECT, THE CALLOS WAS OBSERVED TO BE FRAGMENTED AND HARD. THERE WAS A NON-UNION OF THE BONE AND THE TWO MOST DISTAL ULNAR SCREWS WERE BROKEN AT THE INTERFACE BETWEEN THE BONE AND THE ACUMED VDR PLATE. THE SURGEON HAD TO REMOVE ALL HARDWARE AND THE CALLOS. THE HARDWARE WAS REPLACED WITH A NEW PLATE AND AN ILIAC BONE GRAFT.OTHER MEDICAL DEVICE REPORTS RELATED TO THIS EVENT ARE LISTED BELOW:3025141-2010-000093025141-2010-000103025141-2010-000113025141-2010-00012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEE BLOCK H10 SCREW, FIXATION, BONE HWC ACUMED LLC SEE BLOCK H10 SEE BLOCK H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention