BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI FIXATION PLATE F/CONDYLAR HEAD/0MM

    MDR report key: 12314031 · Received August 12, 2021

    Report

    Report Number
    8030965-2021-06603
    Event Type
    Malfunction
    Date Received
    August 12, 2021
    Date of Event
    July 14, 2021
    Report Date
    July 14, 2021
    Product Code
    NEI
    UDI-DI
    07611819874169
    PMA / PMN Number
    K063181
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW /INVESTIGATION. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. THE PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A SURGERY FOR SEGMENTAL MANDIBULECTOMY AND PLATE RECONSTRUCTION. DURING THE SURGERY, THE SURGEON HAD DIFFICULTIES TO INSERTING THE SCREW INTO THE PLATE BECAUSE HE FELT SCREWING WAS QUITE TIGHT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30-MINUTE SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: CONDYLAR HEAD ADD-ON (PART:04.449.000S;LOT# UNKNOWN; QUANTITY: 1), FIXATION PLATE FOR CONDYLAR HEAD (PART:04.449.010S ;LOT# UNKNOWN; QUANTITY: 1), TITANIUM PATIENT SPECIFIC PLATE (PART:SD480.101;LOT# UNKNOWN; QUANTITY: 1), UNK: SCREWDRIVER: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) TITANIUM CONDYLAR HEAD. THIS REPORT IS 2 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1210754 TI FIXATION PLATE F/CONDYLAR HEAD/0MM PROSTHESIS,CONDYLE,MANDIBULAR TEMPORARY NEI 07611819874169

    Patients

    Seq Age Sex Outcome Treatment
    1 CMD PATIENT SPECIFIC PLATE F/MANDIB MATM| CONDYL-HEAD ADD-ON| MATRIXMANDIBLE SET SCREW F/CONDYL-HEAD A| MATRIXMANDIBLE SET SCREW F/CONDYL-HEAD A| MATRIXMANDIBLE SET SCREW F/CONDYL-HEAD A