BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGERTAPE CERCLAGE W/O NEEDLE

    MDR report key: 20791488 · Received November 27, 2024

    Report

    Report Number
    1220246-2024-08642
    Event Type
    Injury
    Date Received
    November 27, 2024
    Date of Event
    September 3, 2024
    Report Date
    August 21, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAT
    UDI-DI
    00888867369900
    PMA / PMN Number
    K232755
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. THE COMPLAINT COULD NOT BE CONFIRMED BASED ON THE X-RAY IMAGES PROVIDED FROM THE FIELD, AS THE AR-7268T DEVICE DOES NOT APPEAR IN THE SUBMITTED IMAGES. THEREFORE, ARTHREX CONCLUDED THAT THE REPORTED FAILURE WAS MOST LIKELY DUE TO A PATIENT-SPECIFIC EVENT.

    Description of Event or Problem · 0

    ON 10/29/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A 3024-016 16-HOLE LEFT ALPHA PLATE BROKE POSTOPERATIVELY THROUGH THE OBLONG HOLE IN THE FIRST BEND OF THE PLATE. ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH THE PLATE, AND ON (B)(6) 2024, THE PLATE WAS REMOVED. PER THE SALES REPRESENTATIVE, THE PATIENT DID NOT REPORT ANY FALLS OR INJURIES. NO ADDITIONAL INFORMATION HAS BEEN REPORTED. ADDITIONAL INFORMATION RECEIVED ON 11/13/2024: THE CORRECT ORIGINAL SURGERY DATE IS (B)(6) 2024. THE PATIENT WAS IMPLANTED WITH THE 3024-016 16-HOLE LEFT ALPHA PLATE, AN 8110-026 CORTICAL BONE SCREW, TWO 8110-028 CORTICAL BONE SCREWS, FOUR 8114-026 DOUBLE LEAD LOCK CORTICAL SCREW, AN 8114-036 DOUBLE LEAD LOCK CORTICAL SCREW, AN 8124-030 FULLY THREADED CANCELLOUS LOCKING SCREW, AN 8124-032 FULLY THREADED CANCELLOUS LOCKING SCREW, TWO 8124-036 FULLY THREADED CANCELLOUS LOCKING SCREW, TWO 8124-040 FULLY THREADED CANCELLOUS LOCKING SCREW, AN 8124-042 FULLY THREADED CANCELLOUS LOCKING SCREW, TWO AR-7268T TIGERTAPE CERCLAGE WITH FIBERLINK SHUTTLE SUTURE, AND AN ABS-2010-10 ALLOSYNC PURE. DURING THE REVISION SURGERY, ALL THE HARDWARE WAS REMOVED. THE REVISION SURGERY WAS COMPLETED USING A 3012-014 PROXIMAL HUMERAL PLATE, 14-HOLE, WITH ADDITIONAL SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2356444 TIGERTAPE CERCLAGE W/O NEEDLE POLYETHYLENE SYNTHETIC SUTURE GAT ARTHREX, INC. TIGERTAPE CERCLAGE W/O NEEDLE 15149865 00888867369900

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other