BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMMERTOE INSTRUMENT KIT, SIZE MEDIUM

    MDR report key: 8777476 · Received July 10, 2019

    Report

    Report Number
    3014323288-2019-00002
    Event Type
    Injury
    Date Received
    July 10, 2019
    Date of Event
    June 13, 2019
    Report Date
    October 24, 2019
    Manufacturer
    T.A.G. MEDICAL PRODUCTS CORPORATION LTD.
    Product Code
    HTW
    UDI-DI
    10818674021460
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    OSSIO WAS NOTIFIED THAT, ACCORDING TO DOCTOR, ISSUE RESOLVED ITSELF BY AUG 19, 2019.

    Additional Manufacturer Narrative · 1

    MANUFACTURE SHARED THAT: "DHR REVIEW SHOWS NO ISSUE DURING STERILIZATION AND PRODUCT WAS RELEASED ACCORDING TO ROUTINE PROCEDURE." ADDITIONAL REPORTS RELATED TO THIS EVENT ARE: # 3014323288-2019-00001, # 3014554088-2019-00001.

    Description of Event or Problem · 1

    SURGEON ALERTED THE COMPANY REP THAT A PATIENT IS EXPERIENCING SWELLING AND PAIN 6 WEEKS FOLLOWING IMPLANTATION OF OSSIOFIBER HAMMERTOE FIXATION IMPLANT, 2.9X19 (MEDIUM, STRAIGHT) IN A PROXIMAL INTERPHALANGEAL JOINT OF 2ND TOE. INFECTION WAS SUSPECTED AT THE OPERATED SITE OF 2ND TOE. NO SAMPLES WERE SENT FOR DIAGNOSTIC TESTING. PATIENT WAS PRESCRIBED WITH ANTIBIOTICS. DURING IMPLANTATION, HAMMERTOE INSTRUMENTATION, SIZE MEDIUM (T.A.G MEDICAL PRODUCTS CORPORATION LTD.) WERE UTILIZED AS DISPOSABLE INSTRUMENTS FOR THE PREPARATION OF THE IMPLANTATION SITE. DURING THE SAME SURGERY, SCREWS BY ANOTHER MANUFACTURER WERE IMPLANTED IN THE 1ST RAY. A SOFT TISSUE RELEASE PROCEDURE WAS PERFORMED ON THE 5TH TOE. IMPLANT REMOVAL SURGERY FROM THE 2ND TOE WAS SCHEDULED FOR THE SEVENTH-WEEK POST-OP, BUT THE PATIENT DID NOT PRESENT. ADDITIONAL IMAGING WAS PERFORMED ON THE PATIENT EIGHT WEEKS POST-OP. PATIENT WAS RE-SCHEDULED FOR AN MRI AND A REMOVAL OPERATION THE FOLLOWING WEEK. THE PATIENT DID NOT PRESENT AGAIN. PATIENT HAS NOT RESPONDED TO QUERIES AND DOCTOR AND FACILITY HAVE NOT HAD CONTACT WITH PATIENT AFTER OR AWARE OF ANY ADDITIONAL MEDICAL TREATMENT OR CONSULTATION RECEIVED ELSEWHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569365 HAMMERTOE INSTRUMENT KIT, SIZE MEDIUM BIT, DRILL HTW T.A.G. MEDICAL PRODUCTS CORPORATION LTD. 18J01 10818674021460

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention 1ST TOE HAD SCREWS IMPLANTED IN SAME OPERATION| 5TH TOE HAD A SOFT TISSUE RELEASE PROCEDURE| IMPLANT DIPPED IN GENTAMYCIN PRIOR TO IMPLANTATION| IV ANCEF, VANOMYCIN BEFORE PRIMARY SURGERY| OSSIOFIBER HAMMERTOE FIXATION IMPLANT 2.9X19| SCREWS WERE DIPPED IN SAME SOLUTION BEFORE IMPLANT| 1ST TOE HAD SCREWS IMPLANTED IN SAME OPERATION| 5TH TOE HAD A SOFT TISSUE RELEASE PROCEDURE| IMPLANT DIPPED IN GENTAMYCIN PRIOR TO IMPLANTATION| IV ANCEF, VANOMYCIN BEFORE PRIMARY SURGERY| OSSIOFIBER HAMMERTOE FIXATION IMPLANT 2.9X19| SCREWS WERE DIPPED IN SAME SOLUTION BEFORE IMPLANT