BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 8536703 · Received April 22, 2019

    Report

    Report Number
    8030965-2019-63020
    Event Type
    Injury
    Date Received
    April 22, 2019
    Report Date
    March 26, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. (CORRECTED DATA):RESCINDING, 5/1/2019: THE INITIAL COMPLAINT MWR-08042019-0000397703, FOR IP-00547801 WAS REVIEWED AND FOUND NOT REPORTABLE AS THIS COMPLAINT WAS OPENED IN ERROR.. DJR 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

    THIS REPORT IS FOR AN UNKNOWN PLATE/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR 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 A PATIENT UNDERWENT A SECOND REVISION SURGERY ON (B)(6) 2019. INITIALLY, THE PATIENT HAD AN IMPLANTATION ON (B)(6) 2018. HOWEVER, ON (B)(6) 2019, THE PATIENT HAD THE FIRST REVISION SURGERY WHERE THE REMOVAL OF BOTH MANDIBULAR PLATES AND SCREWS WERE PERFORMED AS WELL AS THE GENIOPLASTY PLATE AND SCREWS WERE EXTRACTED DUE TO THE SCREWS IN THE MAXILLARY PLATE WERE ALL LOOSE AND WITH FIBROUS UNION OF THE MAXILLA BUT THIS HAD HEALED OVER. UNFORTUNATELY, ON (B)(6) 2019, THE PATIENT REPORTED THAT THE MAXILLA WAS MOBILE THAT NEEDS FOR A CONVENTIONAL SPLINT AND BOOKED FOR AN ILIAC CREST GRAFTING. THUS, ON (B)(6) 2019, THE PATIENT HAD AN SECOND UNKNOWN SURGERY FOR GRAFTING AT THE LE FORT LEVEL I AND HAD A FIXATION WITH AN UNKNOWN PLATES AND UNKNOWN SCREWS IN THE MAXILLA. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. THIS (B)(4) CAPTURES THE SECOND REVISION SURGERY DUE TO MOBILIZED MAXILLA WHILE (B)(4) CAPTURES THE FIRST REMOVAL SURGERY DUE TO NON-UNION. THIS REPORT IS FOR AN UNKNOWN PLATE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331000 PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention