BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOW PROFILE SCREW, TI, 4.5 X 28MM

    MDR report key: 9751141 · Received February 25, 2020

    Report

    Report Number
    1220246-2020-01708
    Event Type
    Injury
    Date Received
    February 25, 2020
    Date of Event
    January 2, 2020
    Report Date
    February 25, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867124509
    PMA / PMN Number
    K141735
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    501

    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 BY THE PATIENT'S LEGAL REPRESENTATIVE THAT THE PATIENT HAD SUSTAINED A WORK INJURY ON (B)(6) 2019, INJURING A VARIETY OF BODY PARTS IN THAT FALL. PATIENT SUSTAINED INJURIES TO HIS RIGHT LOWER EXTREMITY. SINCE THE INJURY THE PATIENT HAS UNDERGONE SEVERAL PROCEDURES ON HIS RIGHT LOWER EXTREMITY. ON (B)(6) 2019 - EXTERNAL FIXATOR IMPLANTED. AT SOME POINT AFTER THE INITIAL SURGICAL PROCEDURE ON (B)(6) 2019, PATIENT'S RIGHT LOWER EXTREMITY BECAME SEVERELY INFECTED. ON (B)(6) 2019 - EXTERNAL FIXATOR REMOVED AND ORIF CONDUCTED ON RIGHT TIBIAL PILON. THE PRODUCT IMPLANTED IN THE PATIENT DURING THE APRIL PROCEDURES WERE ANOTHER MANUFACTURER'S PRODUCT (NON-ARTHREX). ON (B)(6) 2019 - IRRIGATION AND DEBRIDEMENT, HARDWARE REMOVAL, INSERTION OF ANTIBIOTIC BEADS AND SPACER. ON (B)(6) 2019 - IRRIGATION AND DEBRIDEMENT, RE-INSERTION OF ANTIBIOTIC BEADS AND SPACER. ON (B)(6) 2019 - DEBRIDEMENT AND PREPARATION OF WOUND, SKIN TRANSFER FROM RIGHT THIGH, EXCHANGE OF ANTIBIOTIC SPACER. PATIENT WAS TREATED FOR INFECTION AFTER THE (B)(6) 2019 PROCEDURES UNTIL JUST PRIOR TO THE (B)(6) 2019 PROCEDURE WHERE ARTHREX PRODUCTS WERE IMPLANTED. ON (B)(6) 2019 - IRRIGATION AND DEBRIDEMENT, ANTIBIOTIC SPACER EXCHANGE, BONE BIOPSY AND CULTURE. ON (B)(6) 2019 - REMOVAL OF ANTIBIOTIC SPACER, ANKLE FUSION USING ARTHREX TTC FUSION PLATE. DURING THE (B)(6) 2019 PROCEDURE THE FOLLOWING DEVICES WERE IMPLANTED: AR-8970PL, LOT 5261604, ANKLE FUSION PLATE, POSTERIOR TTC, LEFT, AR-8545-28, LOT 10255239, LOW PROFILE SCREW 4.5 X 28MM, AR-8545-34, LOT 10236575, LOW PROFILE SCREW 4.5 X 34MM, AR-8545-38, LOT 10188917, LOW PROFILE SCREW 4.5 X 38MM, AR-8545L-26, LOT 1051631, LOW PROFILE LOCKING SCREW, 4.5 X 26MM, AR-8545L-30, LOT 1059964, LOW PROFILE LOCKING SCREW 4.5 X 30MM, AR-8545L-34, LOT 1056073, LOW PROFILE LOCKING SCREW 4.5 X 34 MM, AR-8545L-38, LOT 1058918, LOW PROFILE LOCKING SCREW, 4.5 X 38MM. ON (B)(6) 2019 - IRRIGATION AND DEBRIDEMENT, WOUND VAC APPLICATION. ON (B)(6) 2020 - IRRIGATION AND DEBRIDEMENT, COMPLETE REMOVAL OF HARDWARE (PRESUMED TO BE ALL ARTHREX HARDWARE IMPLANTED ON (B)(6) 2019), AND PLACEMENT OF INCISIONAL WOUND VAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214652 LOW PROFILE SCREW, TI, 4.5 X 28MM PLATE, FIXATION, BONE HRS ARTHREX, INC. LOW PROFILE SCREW, TI, 4.5 X 28MM 10255239 00888867124509

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other