BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LO-PRO SCRW,TI,3.5MMX 18MM

    MDR report key: 7861410 · Received September 10, 2018

    Report

    Report Number
    1220246-2018-00638
    Event Type
    Injury
    Date Received
    September 10, 2018
    Date of Event
    April 3, 2018
    Report Date
    September 10, 2018
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867050440
    PMA / PMN Number
    K143614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 DEVICE REMAINS IN THE PATIENT. 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.

    Description of Event or Problem · 1

    A PATIENT REPORTED THAT SHE UNDERWENT A PLANTAR LAPIDUS PROCEDURE ON HER RIGHT FOOT ON (B)(6) 2018. SINCE HER SURGERY PATIENT HAS BEEN EXPERIENCING WHAT SHE FEELS MAY BE POSSIBLE REACTION SYMPTOMS IN AND AROUND THE SURGICAL SITE WHICH INCLUDE: SLOW WOUND HEALING, REDNESS, ROUGH SKIN, SWELLING AND INFLAMMATION WHICH FLARES UP WORSE AT TIMES. PATIENT STATED THAT THERE IS NO INFECTION. PATIENT HAS PLANS TO GO TO AN ALLERGIST FOR ALLERGY TESTING TO THE MATERIALS WHICH COMPRISE HER ARTHREX IMPLANTS. THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED DURING THE (B)(6) 2018 SURGERY: AR-8941PR PLATE (QTY 1), AR-8935-24 CORTICAL SCREW (QTY 1), AR-8935-22 CORTICAL SCREW (QTY 1), AR-8935-28 CORTICAL SCREW (QTY 1) AND AR-8935-18 CORTICAL SCREW (QTY 2). DEVICES ARE TITANIUM AND PATIENT HAS BEEN PROVIDED THE MATERIAL COMPOSITION BREAKDOWN OF THE ASTM TITANIUM STANDARDS OF THE DEVICE MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702193 LO-PRO SCRW,TI,3.5MMX 18MM SCREW, FIXATION, BONE HWC ARTHREX, INC. LO-PRO SCRW,TI,3.5MMX 18MM UNK 00888867050440

    Patients

    Seq Age Sex Outcome Treatment
    1 Other