BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LO-PRO SCRW TM,SS 3.5X 22MMCORT

    MDR report key: 8417432 · Received March 13, 2019

    Report

    Report Number
    1220246-2019-00958
    Event Type
    Injury
    Date Received
    March 13, 2019
    Date of Event
    April 18, 2013
    Report Date
    March 13, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867047327
    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. 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

    IT WAS REPORTED BY A PATIENT THAT SHE HAD UNDERGONE ANKLE SURGERY ON (B)(6) 2013 DURING WHICH TIME ARTHREX DEVICES WERE IMPLANTED. PATIENT MAY POSSIBLY BE HAVING AN ALLERGIC REACTION TO THE IMPLANT MATERIALS AND WAS INQUIRING ABOUT THE MATERIAL COMPOSITION. AT TIME OF INITIAL REPORT PATIENT DID NOT HAVE THE SPECIFIC PRODUCT NUMBERS OF HER IMPLANTS. PATIENT DOES NOT HAVE AN ALLERGY TO METAL BUT DOES HAVE ALLERGIES TO AT LEAST ONE COMPONENT OF TITANIUM, WHICH IS VANADIUM. ADDITIONAL INFORMATION OBTAINED 2/18/19: THE PROCEDURE ON (B)(6) 2013 WAS TO REPAIR AND ANKLE FRACTURE. THE PATIENT'S SYMPTOMS BEGAN SEVERAL MONTH AFTER SURGERY. THE AREA AROUND THE SURGICAL SITE BECAME SWOLLEN WITH SKIN DISCOLORATIONS AS WELL AS TEXTURE WHICH CONTINUE SEVERAL YEARS POST OP. PATIENT HAS FREQUENT FEELINGS OF STIFFNESS AND PRESSURE IN THE AREA AS WELL. PATIENT HAS BEEN TREATED WITH MOBIC (NON-STEROIDAL ANTI-INFLAMMATORY DRUGS). MATERIAL COMPOSITION OF THE IMPLANTED DEVICES, WHICH ARE COMPRISED OF STAINLESS STEEL AND MEET ASTM STANDARDS, HAS BEEN PROVIDED TO THE PATIENT. THE FOLLOWING DEVICES WERE IMPLANTED DURING THE (B)(6) 2013 PROCEDURE: AR-8943BR-06, LOCKING DISTAL FIBULA PLATE, RIGHT 6 HOLE (QTY 1). AR-8835-12, LOW PROFILE NON-LOCKING SCREW 12 MM - CORTICAL (QTY 5). AR-8827L-12, LOW PROFILE LOCKING SCREW 12MM (QTY 2). AR-8827L-14, LOW PROFILE LOCKING SCREW 14MM (QTY 1). AR-8835-22, LOW PROFILE NON-LOCKING SCREW 22MM- CORTICAL (QTY 1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208468 LO-PRO SCRW TM,SS 3.5X 22MMCORT SCREW, FIXATION, BONE HWC ARTHREX, INC. LO-PRO SCRW TM,SS 3.5X 22MMCORT UNK 00888867047327

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other