BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING LATERAL HOOK PLATE, 5 HOLE, SS

    MDR report key: 7285133 · Received February 21, 2018

    Report

    Report Number
    1220246-2018-00058
    Event Type
    Injury
    Date Received
    February 21, 2018
    Date of Event
    February 1, 2014
    Report Date
    February 21, 2018
    Manufacturer
    ARTHREX INC.
    Product Code
    HWC
    UDI-DI
    00888867047365
    PMA / PMN Number
    K103705
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THIS IS ONE OF SIX SUBMISSIONS FOR THE SAME EVENT WHICH ARE (B)(4). LOT NUMBER WAS NOT PROVIDED SO DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED. 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 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. PRODUCT DIRECTIONS FOR USE WARNS OF EFFECTS LIKE FOREIGN BODY AND ALLERGIC-LIKE REACTIONS AS WELL AS INFECTIONS BOTH DEEP AND SUPERFICIAL TO THE IMPLANT MATERIALS. PATIENT SENSITIVITY TO MATERIALS MUST BE CONSIDERED PRIOR TO IMPLANTATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A DERMATOLOGIST'S OFFICE THAT A PATIENT IS CONCERNED HE IS ALLERGIC TO A COMPONENT OF THE PLATE AND SCREWS USED TO FIX HIS ANKLE IN 2015 AFTER HE SUFFERED A BREAK. REPORTER HAS REQUESTED MATERIAL COMPOSITION OF THE DEVICES. THE FOLLOWING ARE THE IMPLANTED DEVICES: AR-8943TH-05, LOCKING LATERAL HOOK PLATE, STAINLESS STEEL ((B)(4)). AR-8835-30, LOW PROFILE CORTICAL SCREW, STAINLESS STEEL ((B)(4)). AR-8835-18, LOW PROFILE CORTICAL SCREW, STAINLESS STEEL ((B)(4)). AR-8835-14, LOW PROFILE CORTICAL SCREW, STAINLESS STEEL ((B)(4)). AR-8840-14, LOW PROFILE CANCELLOUS SCREW, STAINLESS STEEL ((B)(4)). AR-8926SS, KNOTLESS TIGHTROPE SYNDESMOSIS REPAIR IMPLANT. FOLLOW-UP INVESTIGATION: PATIENT'S ORIGINAL SURGERY WAS IN (B)(6) 2014 (NOT 2015 AS ORIGINALLY REPORTED). SPECIFIC DATE IS UNKNOWN. SURGERY WAS AN ORIF OF THE LEFT ANKLE. PATIENT IS A MALE WITH KNOWN ALLERGY TO AMOXICILLIN. PATIENT HAS BEEN EXPERIENCING CHRONIC FATIGUE AND SLEEPINESS, ANXIETY AND PALPITATIONS AND BRADYCARDIA. TREATMENTS TO DATE ARE UNKNOWN. MATERIAL COMPOSITION OF THE IMPLANTED DEVICES HAS BEEN PROVIDED THE REPORTER. DEVICES ARE STAINLESS STEEL. SINCE A SPECIFIC DAY FOR THE ORIGINAL (B)(6) 2014 SURGERY IS UNKNOWN, (B)(6) 2014 WILL BE ENTERED AS DATE OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129690 LOCKING LATERAL HOOK PLATE, 5 HOLE, SS SCREW, FIXATION, BONE HWC ARTHREX INC. UNKNOWN 00888867047365

    Patients

    Seq Age Sex Outcome Treatment
    1 Other