BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERNALBRACE LIGAMENT

    MDR report key: 9631374 · Received January 27, 2020

    Report

    Report Number
    1220246-2020-01606
    Event Type
    Injury
    Date Received
    January 27, 2020
    Date of Event
    November 22, 2019
    Report Date
    January 27, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    UDI-DI
    00888867096080
    PMA / PMN Number
    K101823
    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 BY THE PATIENT THAT SHE HAD AN ORIGINAL ANKLE PROCEDURE (B)(6) 2017. DURING THE SURGERY SIX ARTHREX PRODUCTS WERE IMPLANTED. THE PATIENT DEVELOPED ALLERGIC LIKE REACTION SYMPTOMS AND RECENTLY HAD TO UNDERGO A SECOND SURGERY ON (B)(6) 2019 TO EXPLANT THE ARTHREX DEVICES. PATIENT DID NOT HAVE AN FURTHER DETAILS AT THE TIME OF REPORT BUT WILL PROVIDE SOON. ADDITIONAL INFORMATION 1/8/2020: ORIGINAL PROCEDURE WAS ON (B)(6) 2017 AND WAS A LEFT ANKLE ORIF. FOLLOWING SURGERY THE PATIENT WAS IN THE HOSPITAL FOR THREE NIGHTS. SHE STARTED HAVING RINGING IN HER EARS AND DIZZINESS 3 MONTHS AFTER SURGERY. THIS WAS FOLLOWED BY TIREDNESS, MIGRAINES, AND TMJ ON HER RIGHT SIDE. SHE ALSO DEVELOPED NOTICEABLY DRIER, FLAKY SKIN AND MORE ANXIETY AFTER ABOUT 6 MONTHS. SHE DEVELOPED FOOD INTOLERANCE TO DAIRY AND DEVELOPED A THYROID NODULE AS WELL. PATIENT HAD A SECOND SURGERY ON (B)(6) 2019 TO EXPLANT ALL OF THE ORIGINAL IMPLANT DEVICES. THE SECOND SURGERY WAS PERFORMED BY A DIFFERENT SURGEON AT A DIFFERENT FACILITY. THE FOLLOWING DEVICES WERE REPORTED TO HAVE BEEN IMPLANTED (B)(6) 2017 AND EXPLANTED (B)(6) 2019 (SPECIFIC ARTHREX PART NUMBERS WERE NOT PROVIDED): AR-8926SS, KNOTLESS TIGHTROPE SYNDESMOSIS REPAIR IMPLANT, LOT 17016. AR-1688-CP, IMPLANT SYSTEM, INTERNAL BRACE LIGAMENT AUGMENTATION REPAIR WITH COLLAGEN COATED FIBERTAPE, LOT 10127689. AR-8943BL-04, LOCKING DITAL FIBULA PLATE, SS, LEFT, 4 HOLE, LOT UNKNOWN. AR-8827L-10, QTY 2, LOW PROFILE LOCKING SCREW, SS, 2.7 X 10MM. AR-8827L-12. LOW PROFILE LOCKING SCREW, SS, 2.7 X 12MM. AR-8835-14, QTY 3, LOW PROFILE NONLOCKING CORTICAL SCREW, SS, 3.5 X 14 MM. PATIENT REPORTS SHE DID NOT KEEP THE IMPLANTS BECAUSE SHE DID NOT WANT THEM. PATIENT ALSO STATED THE TISSUE LOOKED OK BUT THAT IT DOES NOT RULE OUT METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94147 INTERNALBRACE LIGAMENT FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. INTERNALBRACE LIGAMENT 10127689 00888867096080

    Patients

    Seq Age Sex Outcome Treatment
    1