BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - DISTRACTOR IMPLANTS: CURVILINEAR

    MDR report key: 11761625 · Received May 3, 2021

    Report

    Report Number
    8030965-2021-03496
    Event Type
    Injury
    Date Received
    May 3, 2021
    Report Date
    April 7, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    MQN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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. THIS REPORT IS FOR AN UNK -DISTRACTOR IMPLANTS: CURVILINEAR PLATE/SCREWS/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI 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. 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: IVANOV, A.L., CHIKUROV, G.YU., NADTOCHIY, A.G., AND STARICOVA, N.V. (2016), APPLICATION OF SEMI-BURIED CURVILINEAR DISTRACTION DEVICES IN COMPLEX MANAGEMENT OF LOWER MICROGNATHIA IN CHILDREN, DENTISTRY, VOL. 2 (XX), PAGES 37-48 (RUSSIA). THE AIM OF THIS STUDY IS TO IMPROVE THE TREATMENT QUALITY FOR CHILDREN WITH CONGENITAL DEFECTS OF THE LOWER JAW BY INTRODUCING INTO PRACTICE COMPRESSION DISTRACTION DEVICES (CDD) WITH CURVILINEAR DISTRACTION PATHS. A TOTAL OF 7 PATIENTS (4 MALE AND 3 FEMALE) WITH AN AVERAGE AGE OF 6 YEARS (RANGE 3 TO 13 YEARS) WERE INCLUDED IN THE STUDY. SURGERY WAS PERFORMED USING SYNTHES CURVILINEAR COMPRESSION DISTRACTION DEVICES (CDD). THE MEAN FOLLOW-UP PERIOD WAS UNKNOWN. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: IN 1 PATIENT, DISOCCLUSION WAS NOT ELIMINATED; HOWEVER, IT WAS POSSIBLE TO REDUCE THE VERTICAL INTERDENTAL SPACE AND CONDITIONS WERE CREATED FOR FURTHER ORTHODONTIC TREATMENT. IN 3 PATIENTS, A HYPERTROPHIC REGENERATE WAS OBSERVED WHICH REQUIRED DISTRACTION RATE CORRECTION. IN 2 PATIENTS, A HYPOTROPHIC REGENERATE WAS OBSERVED WHICH REQUIRED DISTRACTION RATE CORRECTION. AN UNKNOWN NUMBER OF PATIENTS HAD SCARS FORMED AFTER ITS USE OF CDD WHICH LIMIT THE GROWTH OF THE LOWER JAW AND LEAD TO LOCAL BONE TISSUE ATROPHY. THIS REPORT IS FOR AN UNKNOWN SYNTHES CURVILINEAR DISTRACTOR IMPLANTS. THIS REPORT IS FOR AN UNKNOWN SYNTHES CURVILINEAR INTERNAL MANDIBULAR DISTRACTOR. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658429 UNK - DISTRACTOR IMPLANTS: CURVILINEAR MANDIBLE DISTRACTION DEVICES MQN SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention