BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LO-PRO SCRW TM,SS 3.5X 35MMCORT

    MDR report key: 8916294 · Received August 21, 2019

    Report

    Report Number
    1220246-2019-01259
    Event Type
    Injury
    Date Received
    August 21, 2019
    Date of Event
    September 15, 2018
    Report Date
    August 21, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867047396
    PMA / PMN Number
    K143614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. AT TIME OF REPORT THE DEVICE REMAINS IN THE PATIENT. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    A PATIENT'S RELATIVE HAS REPORTED THAT THE PATIENT HAD AN ANKLE ALLOGRAFT PROCEDURE IN (B)(6) 2018. DURING THE SURGERY AN ARTHREX PLATE AND SCREWS WERE IMPLANTED. SINCE THAT SURGERY THE PATIENT DEVELOPED MULTIPLE SYMPTOMS WHICH ARE BELIEVED TO BE AUTO-IMMUNE RELATED. THE PATIENT HAS TESTED POSITIVE FOR HAVING A NICKEL ALLERGY. PATIENT'S RELATIVE REPORTS THAT IT HAS BEEN SUGGESTED THAT IF PATIENT'S IMPLANTS CONTAIN NICKEL THIS COULD POSSIBLY BE THE CAUSE OF HER SYMPTOMS. SURGEON HAS TOLD THEM THE IMPLANTS RECEIVED DURING THE 2018 SURGERY WERE TITANIUM. REPORTER WAS REQUESTING THE MATERIAL COMPOSITION OF THE IMPLANT DEVICES TO DETERMINE IF THERE MAY POSSIBLY BE SOME NICKEL WITHIN THE COMPOSITION THAT COULD BE CAUSING THE PATIENT'S ISSUES. IN ADDITION TO THE AUTO-IMMUNE LIKE SYMPTOMS THE PATIENT'S RELATIVE STATES THAT THE PATIENT'S ANKLE REPAIR SURGERY WILL NEED TO BE REVISED BECAUSE THE REPAIR DID NOT WORK AND SHE IS UNABLE TO WALK OR PUT PRESSURE ON THAT ANKLE. SPECIFIC ARTHREX PART NUMBERS INVOLVED WERE UNKNOWN AT TIME OF INITIAL REPORT. REPORTER WILL OBTAIN AND PROVIDE. ADDITIONAL INFORMATION OBTAINED 7/31/2019: SALES REP HAS OBTAINED AND PROVIDED THE PATIENT IMPLANT PART NUMBERS. THE FOLLOWING WERE IMPLANTED DURING THE (B)(6) 2018 PROCEDURE: AR-8943T-08 (TIBIAL TUBULAR LOCKING LOW PROFILE PLATE 8 HOLE) LOT 10182311 (QTY 1), AR-8835-10 (CORTICAL SCREW LOW PROFILE) LOT 10217748 (QTY 1), AR-8835-12 (CORTICAL SCREW LOW PROFILE) LOT 10212120 (QTY 2), AR-8835-14 (CORTICAL SCREW LOW PROFILE) LOT 10209304 (QTY 1), AR-8835-14 (CORTICAL SCREW LOW PROFILE) LOT 10234636 (QTY 1), AR-8835-35 (CORTICAL SCREW LOW PROFILE) LOT 10223071 (QTY 1), AR-8835-40 (CORTICAL SCREW LOW PROFILE) LOT 10231400 (QTY 1), AR-8835-40 (CORTICAL SCREW LOW PROFILE) LOT 10210894 (QTY 1), AR-8730-34H (MINI FT COMPRESSION SCREW) LOT 10215096 (QTY 1). THE AR-8730-34H IS COMPRISED OF TITANIUM ALLOY. THE REMAINING DEVICES ARE ALL COMPRISED OF STAINLESS STEEL. ALSO IMPLANTED DURING THE (B)(6) 2018 SURGERY WAS AN ALLOSOURCE (ALLOGRAFT TIB DIST FRESH OSTEOCHONDRAL) GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707662 LO-PRO SCRW TM,SS 3.5X 35MMCORT SCREW, FIXATION, BONE HWC ARTHREX, INC. LO-PRO SCRW TM,SS 3.5X 35MMCORT 10223071 00888867047396

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other