BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LO-PRO SCRW,TI,3.5MMX 34MM

    MDR report key: 8526645 · Received April 18, 2019

    Report

    Report Number
    1220246-2019-01053
    Event Type
    Injury
    Date Received
    April 18, 2019
    Date of Event
    November 20, 2017
    Report Date
    April 18, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867050600
    PMA / PMN Number
    K143614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. A POSSIBLE CAUSE OF THIS TYPE OF EVENT MAY BE A REACTION OF THE PATIENT TO THE MATERIAL(S) IMPLANTED OR USED DURING THE IMPLANT PROCEDURE. PATIENT SENSITIVITY TO MATERIALS MUST BE CONSIDERED PRIOR TO IMPLANTATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PATIENT, THROUGH THE ARTHREX WEBSITE, THAT SHE HAD UNDERGONE A CALCANEUS REPAIR PROCEDURE (B)(6) 2017. LESS THAN TWO WEEKS POST SURGERY PATIENT'S BACK STARTED ITCHING AND THIS HAS SINCE SPREAD ALL OVER HER BODY AND PATIENT REPORTS THIS IS CAUSING HER GREAT STRESS AND LACK OF SLEEP. AT THE TIME OF INITIAL REPORT THE PATIENT DID NOT HAVE THE ARTHREX PRODUCT NUMBERS FOR HER IMPLANTS. PATIENT HAS REQUESTED AND WILL BE PROVIDED WITH THE MATERIAL COMPOSITION OF HER IMPLANTS ONCE THE PART NUMBERS ARE PROVIDED TO ARTHREX. ADDITIONAL INFORMATION OBTAINED 4/3/2019: PATIENT HAS PROVIDED THE IMPLANT LOG FROM HER SURGERY. THE FOLLOWING ARE THE PATIENT'S ARTHREX IMPLANT PART NUMBERS. LOT NUMBERS WERE NOT PROVIDED ON THE IMPLANT LOG AND ARE NOT AVAILABLE: CALCANEUS PLATE: AR-8954PR-XS (QTY 1), 3.5MM LOCKING SCREWS: AR-8935L-28 (QTY2), AR-8935L-22 (QTY 1), 3.5MM NON-LOCKING SCREWS:(QTY 1 EACH) AR-8935-38, AR-8935-36, AR-8935-34, AR-8935-30, AR-8935-26, AR-8935-24. MATERIAL COMPOSITION OF THE IMPLANTED DEVICES IS BEING PROVIDED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319441 LO-PRO SCRW,TI,3.5MMX 34MM PLATE, FIXATION, BONE HWC ARTHREX, INC. LO-PRO SCRW,TI,3.5MMX 34MM UNK 00888867050600

    Patients

    Seq Age Sex Outcome Treatment
    1 Other