BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1ST MTP 0 DEGREE DORSIFLEXED,LT,9-HOLE

    MDR report key: 14084240 · Received April 12, 2022

    Report

    Report Number
    2031009-2022-00002
    Event Type
    Malfunction
    Date Received
    April 12, 2022
    Date of Event
    March 15, 2022
    Report Date
    May 25, 2022
    Manufacturer
    TRIMED INC
    Product Code
    HRS
    UDI-DI
    00842188119989
    PMA / PMN Number
    K192696
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS STATED ON (B)(6) 2022 THAT THE SURGEON DOES NOT BELIEVE THE PLATE ITSELF CAUSED OR CONTRIBUTED TO THE SERIOUS INJURY.

    Description of Event or Problem · 0

    A TRIMED SALES REPRESENTATIVE REPORTED ON (B)(6) 2022 THAT A MTPL-9 HAD BROKEN IN THE PATIENT. IT WAS STATED THAT THE SURGEON HAD A (B)(6) PATIENT WHO HAD A PREVIOUSLY FAILED TOE IMPLANT (NOT A TRIMED PRODUCT), THE SURGEON REMOVED THE SILASTIC IMPLANT AND PUT AN ALLOGRAFT BONE WEDGE IN AND PLATED WITH THE MTPL-9. IT WAS STATED BY THE SALES REP AND SURGEON THAT THE FRACTURE LOOKED FUSED AND WAS DOING WELL WHEN THERE WAS A SUDDEN ONSET OF PAIN 3 MONTHS POST SURGERY (INITIAL SURGERY DATE UNKNOWN), IT WAS ALSO MENTIONED THAT THE PATIENT TYPICALLY HAS SURGERY COMPLICATIONS. LASTLY, IT WAS STATED THAT THE SURGEON PLANS TO REMOVE THE HARDWARE, THE SURGERY DATE IS CURRENTLY UNKNOWN. THE SURGEON DOES NOT BELIEVE THAT THIS ISSUE WILL CAUSE ANY LASTING ISSUES IN THE PATIENT.

    Description of Event or Problem · 0

    A TRIMED SALES REPRESENTATIVE REPORTED ON 26 APR 2022 THAT THE SURGEON DOES NOT BELIEVE THE PLATE ITSELF CAUSED OR CONTRIBUTED TO THE SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247980 1ST MTP 0 DEGREE DORSIFLEXED,LT,9-HOLE 1ST MTP 0 DEGREE DORSIFLEXED,LT,9-HOLE HRS TRIMED INC MTPL-9 00842188119989

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Other| R