BEUDAMED
    FDA Adverse Event Death Summary report: N

    MANDIBLE DISTRACTION DEVICES

    MDR report key: 7168589 · Received January 5, 2018

    Report

    Report Number
    8030965-2018-50106
    Event Type
    Death
    Date Received
    January 5, 2018
    Report Date
    December 28, 2017
    Manufacturer
    OBERDORF : SYNTHES PRODUKTIONS GMBH
    Product Code
    MQN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT IS UNKNOWN. DATE OF DEATH IS UNKNOWN. DATE OF EVENT: UNKNOWN. THIS REPORT IS FOR AN UNKNOWN A/O UNIDIRECTIONAL DISTRACTION DEVICE/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. IMPLANT DATE: UNKNOWN. EXPLANT DATE: UNKNOWN. 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE RUBIO-BUENO, P., NAVAL, L., RODRIGUEZ-CAMPO, F., GIL-DIEZ, J. AND DIAZ-GONZALEZ, F. (2005) INTERNAL DISTRACTION OSTEOGENESIS WITH A UNIDIRECTIONAL DEVICE FOR RECONSTRUCTION OF MANDIBULAR SEGMENTAL DEFECTS. J ORAL MAXILLOFAC SURG 63:598-60. (SPAIN) THE PURPOSE OF THIS ARTICLE IS TO SHOW THE AUTHORS¿ PRELIMINARY SERIES OF BONE TRANSPORT BY DISTRACTION OSTEOGENESIS (DO) WITH A UNIDIRECTIONAL SUBMERGED DEVICE TO RECONSTRUCT DIFFERENT DEGREES OF MANDIBULAR SEGMENTAL DEFECTS. THIS STUDY INCLUDED FIVE (5) PATIENTS, CONSISTING OF THREE (3) MALES AND TWO (2) FEMALES BETWEEN THE AGES OF 48 YEARS TO 78 YEARS, WHO HAVE BEEN TREATED WITH MANDIBULAR DISTRACTION OSTEOGENESIS TO RECONSTRUCT DIFFERENT ACQUIRED SEGMENTAL DEFECTS. THESE MANDIBULAR DEFECTS (35 TO 80 MM IN LENGTH) WERE RECONSTRUCTED BY MEANS OF INTERNAL DISTRACTION DEVICES WITH A TRANSCUTANEOUS ACTIVATOR. ALL THE PATIENTS UNDERWENT COMPLETE RESECTION OF THE AFFECTED BONE AND IMMEDIATE PLACEMENT OF THE DISTRACTION DEVICE ON THE REMAINING MANDIBLE. FOLLOW UP MONTHS SINCE THE RESECTIVE SURGERY WAS FROM 4 MONTHS TO 43 MONTHS. COMPLICATION ¿ -CASE 1 ((B)(6), MALE), WHO SHOWED A COMPLETE INTRAORAL EXPOSURE OF THE DISTRACTION DEVICE; THEREFORE, HE WAS RETURNED TO THE OPERATING ROOM, WHERE HE UNDERWENT REMOVAL OF THE DEVICE. HE LATER DIED. - CASE 2 ((B)(6), FEMALE), WHO DIED OF DISTANT METASTASES 4 MONTHS AFTER THE RESECTIVE SURGERY; IN THIS CASE, DISTRACTION WAS NOT COMPLETED BECAUSE OF THE DETERIORATED GENERAL STATUS OF THE PATIENT. - CASE 3 ((B)(6), MALE), HAD MAXIMUM ORAL OPENING DECREASED. - CASE 4 ((B)(6), FEMALE), SUFFERED FROM LOCAL RECURRENCE 16 MONTHS AFTER THE REMOVAL OF THE SECOND DISTRACTION DEVICE, AND AN ABLATIVE SURGERY WAS PERFORMED TO RESECT THE DISTRACTED BONE. IN THIS CASE, A MICROVASCULARIZED FIBULAR FLAP WAS USED TO RECONSTRUCT THE DEFECT. PATIENT SUFFERED PAIN AT THE END OF THE DISTRACTION PERIOD AND HAD SLIGHT ASYMMETRY. - CASE 5 ((B)(6), MALE), HAD PARTIAL INTRAORAL EXPOSURE. THIS REPORT IS FOR CASE 1. THIS IS REPORT 1 OF 3 FOR (B)(4). THIS REPORT IS FOR UNKNOWN ¿ A/O UNIDIRECTIONAL DISTRACTION DEVICE. THIS REPORT IS FOR 1 DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11594 MANDIBLE DISTRACTION DEVICES MQN OBERDORF : SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| R