BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI FIXATION PLATE F/CONDYLAR HEAD/6MM

    MDR report key: 3737670 · Received April 9, 2014

    Report

    Report Number
    1000562954-2014-10043
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 24, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    NEI
    PMA / PMN Number
    PK063181
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT FOR DIAGNOSIS. IMPLANT DATE: UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED A TREATMENT, NOT DIAGNOSIS ADDITIONAL NARRATIVE: MANUFACTURER: REPORTED AS (B)(4) ON THE INITIAL MEDWATCH WITHOUT A LOT NUMBER PROVIDED. NOT IMPLANTED. 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

    IT WAS REPORTED THAT THE FOLLOWING EVENT OCCURRED DURING A SECONDARY MANDIBLE RESECTION PROCEDURE ON (B)(6) 2014. THIS WAS A REVISION OF THE INITIAL MANDIBLE RESECTION SURGERY, DUE TO A RECURRENCE OF CANCER. INITIAL RESECTION SURGERY WAS PERFORMED ON AN UNKNOWN DATE. THE INITIAL PATIENT SPECIFIC PLATE CONTOURING MATRIX MANDIBLE PLATE AND CONDYLAR HEAD ADD-ON SYSTEM WERE REMOVED. DURING THE REVISION SURGERY, THE SURGEON HAD DIFFICULTY ENGAGING THE SCREWS OF THE CONDYLAR ADD-ON PLATE TO THE PATIENT SPECIFIC PLATE CONTOURING CUSTOM IMPLANT. THREE OF THE SCREWS STRIPPED, AND COULD NOT BE USED. THE SURGEON HAD TO STOP, REASSESS THE BEND OF THE PLATE AND THEN BEND AND FILE THE PLATE A LITTLE MORE IN ORDER TO THE INTERFACE BETWEEN THE PLATE AND THE CUSTOM IMPLANT SO THAT THE SCREWS WOULD ENGAGE THE IMPLANT. ANOTHER SET WAS OPENED FOR ADDITIONAL SCREWS. THE PROCEDURE WAS PROLONGED BY 25 MINUTES TO MANIPULATE THE PLATE AND SECURE ADDITIONAL SCREWS TO COMPLETE THE PROCEDURE. PATIENT WAS STABLE FOLLOWING THE REVISION SURGERY. THERE IS NO ALLEGATION OF DEFICIENCY AGAINST PART SD449.511B (TITANIUM IMPLANT PATIENT SPECIFIC PLATE CONTOURING MATRIX MANDIBLE 7X23H ANGLE RECON PL/RIGHT/2.5MM) AND PART 04.449.000 (TITANIUM CONDYLAR HEAD). THIS IS 4 OF 4 REPORTS FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215202 TI FIXATION PLATE F/CONDYLAR HEAD/6MM PROSTHESIS,CONDYLE,MANDIBULAR TEMPORARY NEI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR