BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PLATES: 2.0 MM LOCK MANDIBLE MINIPLATE

    MDR report key: 12485015 · Received September 16, 2021

    Report

    Report Number
    8030965-2021-07820
    Event Type
    Injury
    Date Received
    September 16, 2021
    Report Date
    August 20, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN 2.0 MM LOCK MANDIBLE MINIPLATE/ 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. 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

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: CARLWIG K, ET AL. (2021), MANDIBULOTOMY ACCESS TO TUMOUR SITES: FEWER COMPLICATIONS FOR POSTOPERATIVE COMPARED WITH PREOPERATIVE RADIOTHERAPY, INT. J. ORAL MAXILLOFAC. SURG., VOLUME 50, PAGES 851-856 (SWEDEN). THE PURPOSE OF THIS STUDY WAS TO COMPARE COMPLICATION RATES AT THE MANDIBULOTOMY SITE BETWEEN PATIENTS RECEIVING PREOPERATIVE RADIOTHERAPY AND THOSE RECEIVING POSTOPERATIVE RADIOTHERAPY DURING TREATMENT FOR ORAL AND OROPHARYNGEAL CANCER WHERE THE SURGICAL PROCEDURE REQUIRED A MANDIBULAR OSTEOTOMY TO GAIN ACCESS TO THE TUMOUR. DURING THE PERIOD JANUARY 2000 TO AUGUST 2015, 64 PATIENTS WHO UNDERWENT MULTIMODALITY CURATIVE TREATMENT WITH SURGERY INCLUDING MANDIBULOTOMY AND RADIOTHERAPY FOR MALIGNANT TUMOURS IN, OR EXTENDING INTO, THE ORAL/ OROPHARYNGEAL CAVITY WERE INCLUDED IN THE STUDY. THERE WERE 36 MALES AND 28 FEMALES WITH A MEAN AGE OF 60 YEARS (RANGE 22-84 YEARS). THE UNKNOWN SYNTHES COMPACT 2.0 UNILOCK PLATE SYSTEM WAS USED DURING THE SURGICAL MANDIBULOTOMY FOR ALL PATIENTS. REGARDING THE TIMING OF RADIOTHERAPY IN RELATION TO SURGERY, 3 SPECIFIC GROUPS WERE IDENTIFIED: PREOPERATIVE RADIOTHERAPY (15 PATIENTS), POSTOPERATIVE RADIOTHERAPY (31 PATIENTS), AND A MIXED GROUP (18 PATIENTS). THE PATIENTS RECEIVING THEIR FIRST AND ONLY RADIOTHERAPY WITHIN 6 MONTHS PRIOR TO THE MANDIBULOTOMY CONSTITUTED THE PREOPERATIVE RADIOTHERAPY GROUP, THOSE RECEIVING THEIR FIRST AND ONLY RADIOTHERAPY WITHIN 6 MONTHS FOLLOWING SURGERY CONSTITUTED THE POSTOPERATIVE RADIOTHERAPY GROUP, AND ALL OTHERS WERE PLACED IN THE MIXED GROUP. ALL PATIENTS WERE FOLLOWED FOR AT LEAST 1 YEAR POSTOPERATIVELY. COMPLICATIONS WERE REPORTED AS FOLLOWS: PREOPERATIVE RADIOTHERAPY GROUP. 8 PATIENTS HAD OROCUTANEOUS FISTULA. 6 PATIENTS HAD BONE EXPOSURE. 4 PATIENTS HAD NONUNION. 1 PATIENT HAD PLATE EXPOSURE. 2 PATIENTS HAD OSTEORADIONECROSIS. POSTOPERATIVE RADIOTHERAPY GROUP 1 PATIENT HAD OROCUTANEOUS FISTULA. 1 PATIENT HAD BONE EXPOSURE. 1 PATIENT HAD OSTEORADIONECROSIS. MIXED RADIOTHERAPY GROUP: 5 PATIENTS HAD OROCUTANEOUS FISTULA. 2 PATIENTS HAD BONE EXPOSURE. 1 PATIENT HAD NONUNION. 1 PATIENT HAD OSTEORADIONECROSIS. THIS REPORT IS FOR THE UNKNOWN SYNTHES 2.0 MM LOCK MANDIBLE MINIPLATE SYSTEM. IT CAPTURES THE REPORTED EVENT OF PLATE EXPOSURE. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1382554 UNK - PLATES: 2.0 MM LOCK MANDIBLE MINIPLATE PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention