BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAV FRAC PLT,CENTRAL THIRD,RT,SS

    MDR report key: 8732551 · Received June 25, 2019

    Report

    Report Number
    1220246-2019-01157
    Event Type
    Injury
    Date Received
    June 25, 2019
    Date of Event
    August 21, 2018
    Report Date
    June 25, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867027459
    PMA / PMN Number
    K143139
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA THE PATIENT'S LEGAL REPRESENTATIVE THAT THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION OF RIGHT CLAVICLE FRACTURE PROCEDURE ON (B)(6) 2018 AFTER THE PATIENT HAD SUFFERED AN INJURY IN A MOTOR VEHICLE COLLISION APPROXIMATELY 5 WEEKS PRIOR. THE OPERATIVE REPORT FROM THE (B)(6) 2018 PROCEDURE NOTES THE PATIENT IS A SMOKER AND ALSO NOTES A HIGH RISK OF NON-UNION AND LARGE DISPLACEMENT GREATER THAN 100%. THE PATIENT CHOSE TO PROCEED WITH THE PROCEDURE AND DURING THE PROCEDURE THE FOLLOWING ARTHREX PRODUCT WERE RECORDED AS HAVING BEEN IMPLANTED: AR-2653CR (LOT 5261643) ¿ CLAVICLE PLATE QTY 1. AR-8835-16 (LOT 10204570) ¿ LOW PROFILE SCREW QTY 2. AR-8835-22 (LOT 10034710) ¿ LOW PROFILE SCREW QTY 1. AR-8835L-14 (LOT W50298) ¿ LOW PROFILE LOCKING SCREW QTY 2. AR-8835L-16 (LOT 10181718) ¿ LOW PROFILE LOCKING SCREW QTY 3. AR-8835L-18 (LOT 1194485) ¿ LOW PROFILE LOCKING SCREW QTY 1. AR-8835L-22 (LOT A43035)¿ LOW PROFILE LOCKING SCREW QTY 1. ON (B)(6) 2018 THE PATIENT UNDERWENT A REVISION SURGERY DUE TO POST OPERATIVE FIXATION FAILURE. THE OPERATIVE REPORT NOTED A RIGHT CLAVICLE HARDWARE REMOVAL AND RIGHT CLAVICLE OPEN REDUCTION INTERNAL FIXATION WITH INTERCALARY STRUT ALLOGRAFT. THE OPERATIVE REPORT DOES NOT REFERENCE WHICH ARTHREX DEVICES WERE REMOVED. PHOTOS PROVIDED TO ARTHREX SHOWS AN EXPLANTED BROKEN PLATE AND 8 SCREWS, NOT 10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525985 CLAV FRAC PLT,CENTRAL THIRD,RT,SS PLATE, FIXATION, BONE HRS ARTHREX, INC. CLAV FRAC PLT,CENTRAL THIRD,RT,SS 5261643 00888867027459

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other