BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSCLIP

    MDR report key: 15501585 · Received September 29, 2022

    Report

    Report Number
    3020584246-2022-00026
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    November 28, 2018
    Report Date
    September 26, 2022
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    JDR
    UDI-DI
    00815432023325
    PMA / PMN Number
    K142727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING LHR'S HAVE BEEN REVIEWED AND NO EVIDENCE HAS BEEN FOUND TO SUGGEST THE IMPLANTS DID NOT MEET SPECIFICATIONS PRIOR TO DISTRIBUTION. DESCRIPTION, PART NUMBER, LOT NUMBER: DYNAFORCE HIMAX KIT 18MM X 18MM 7118-1818KT 300055; DYNAFORCE HIMAX IMPLANT 18MM X 18MM ELECTROPOLISHED 240008EP 103068; DYNAFORCE HIMAX IMPLANT 18MM X 18MM ELECTROPOLISHED 240008EP 102887R; DYNAFORCE HIMAX IMPLANT 18MM X 18MM ELECTROPOLISHED 240008EP 103043.

    Description of Event or Problem · 0

    REP REPORTS THAT DOCTOR PERFORMED A 2ND AND 3RD TMT FUSION CASE WITH 4 CLIPS. UPON FOLLOW-UP POST-PROCEDURE, THE MOST MEDIAL CLIP ON THE 2ND TMT FUSION APPEARED BROKEN ON X-RAY WHICH WAS ONE OF THE THREE 18MM X 18MM HIMAX IMPLANTS USED IN THE CASE. REP REPORTS THAT THE PATIENT IS DOING FINE AND THE JOINT HAS EXPERIENCED PROPER FUSION. NO REVISION SURGERY IS PLANNED TO DATE. NO RESOLUTION. PATIENT IS REPORTED TO BE DOING OKAY AND JOINT IS PROPERLY FUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1955537 CROSSCLIP STAPLE, FIXATION, BONE JDR CROSSROADS EXTREMITY SYSTEMS 7118-1818KT 300055 00815432023325

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Other