BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 8636560 · Received May 23, 2019

    Report

    Report Number
    8030965-2019-64428
    Event Type
    Injury
    Date Received
    May 23, 2019
    Report Date
    April 24, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR A SYNTHES AO LOCKING MINI PLATES/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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: TOMOAKI IMAI ET. AL (2019), SURGICAL APPROACHES FOR CONDYLAR FRACTURES RELATED TO FACIAL NERVE INJURY: DEEP VERSUS SUPERFICIAL DISSECTION, INTERNATIONAL JOURNAL OF ORAL & MAXILLOFACIAL SURGERY, PAGES 1-8 (JAPAN)DOI.ORG/10.1016/J.IJOM.2019.02.003. THE AIM OF THIS ARTICLE IS TO INVESTIGATE THE PROBABILITY OF FACIAL NERVE INJURY (FNI) IN THE TREATMENT OF CONDYLAR NECK AND SUBCONDYLAR FRACTURES (CN/SCFS) WITH PERCUTANEOUS APPROACHES AND TO IDENTIFY FACTORS PREDICTING FNI. BETWEEN JANUARY 2010 TO AUGUST 2018, A TOTAL OF 80 PATIENTS WITH 87 FRACTURES WERE 73 PATIENTS UNDERWENT UNILATERAL AND 7 PATIENTS UNDERWENT BILATERAL SURGERY (50 MALE AND 30 FEMALE) WITH A MEAN AGE OF 46.3 YEARS WERE INCLUDED IN THE STUDY. THE PATIENTS WERE DIVIDED INTO GROUPS ACCORDING TO FACIAL NERVE INJURY PRESENCE OR ABSENCE AT 1 WEEK AFTER SURGERY. IN ALL THE APPROACH THE PLATES USED WERE AO LOCKING MINIPLATES OR MATRIX MANDIBLE WAS PLACE ALONG THE RAMUS. THE MEAN DURATION OF FOLLOW-UP WAS UNKNOWN. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: OF THE 22 PATIENTS (27.5%) WITH FNI, 7 (31.8%, OR 8.8% OF THE TOTAL STUDY PATIENTS) HAD PROLONGED PARALYSIS FOR MORE THAN 3 MONTHS. OF THE PROLONGED PARALYSIS CASES, 2 (28.6%, OR 2.5% OF THE TOTAL STUDY PATIENTS) TREATED USING THE TRADITIONAL SUBMANDIBULAR APPROACH (I.E., DEEP GROUP) ALSO HAD PARALYSIS OF THE MMB AT THEIR 6-MONTH VISIT. PLATE BREAKAGE OCCURRED IN 1 PATIENT WITH A DISPLACED CONDYLAR NECK FRACTURE. THIS REPORT IS FOR A SYNTHES AO LOCKING MINI PLATES. THIS IS REPORT 1 OF 9 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432262 PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention