BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: CMF

    MDR report key: 9132248 · Received September 27, 2019

    Report

    Report Number
    2939274-2019-61004
    Event Type
    Injury
    Date Received
    September 27, 2019
    Report Date
    September 3, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN CMF SCREWS/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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: KABAN, L. ET AL. (2009), CLINICAL APPLICATION OF CURVILINEAR DISTRACTION OSTEOGENESIS FOR CORRECTION OF MANDIBULAR DEFORMITIES, JOURNAL OF ORAL AND MAXILLOFACIAL SURGERY, VOL. 67(5), PAGES 996-1008 (USA). THE PURPOSE OF THIS STUDY IS TO REPORT THE CLINICAL APPLICATION OF A SEMIBURIED, FIXED-TRAJECTORY, CURVILINEAR DISTRACTION DEVICE, USED IN CONJUNCTION WITH A CT-BASED 3D TREATMENT PLANNING SYSTEM, TO CORRECT MANDIBULAR DEFORMITIES. A TOTAL OF 13 PATIENTS (5 MALES AND 8 FEMALES) WITH A MEAN AGE OF 11.9 YEARS (RANGE 15 MONTHS TO 39 YEARS) UNDERWENT BILATERAL MANDIBULAR OSTEOTOMIES AND PLACEMENT OF CUSTOM-MADE CURVILINEAR DISTRACTION DEVICES (SYNTHES CMF, (B)(4)). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 3 PATIENTS HAD A DISTRACTOR PLACEMENT RESULTED IN A LESS-THAN-IDEAL JAW POSITION. THE DEVICES WERE REMOVED HALFWAY THROUGH THE FIXATION PERIOD, BEFORE COMPLETE BONE FORMATION. THE DESIRED JAW POSITION WAS ACHIEVED BY ¿MOLDING¿ THE REGENERATE AND IMMOBILIZING THE JAW UNTIL HEALING HAD OCCURRED. THESE 3 PATIENTS HAD NOT HAD THE BENEFIT OF PLANNING WITH THE 3D MODEL AND ACRYLIC TEMPLATE, WHICH ELIMINATED THIS PROBLEM IN SUBSEQUENT CASES. 1 PATIENT, 1 OF THE DEVICES FAILED AFTER DISTRACTION WAS COMPLETED. DURING THE FIXATION PERIOD, THE DEVICE TURNED BACK ON ITSELF, AND THE JAW POSITION REGRESSED. THE DEVICE WAS ACTIVATED AGAIN, THE CORRECT JAW POSITION WAS ACHIEVED, AND THE PATIENT WAS PLACED IN MAXILLOMANDIBULAR FIXATION UNTIL THE GAP HAD FILLED IN WITH BONE. ANALYSIS OF THE DISTRACTOR REVEALED A MALFUNCTION OF THE STOP THAT PREVENTS SPONTANEOUS REVERSAL OF THE DEVICE. THIS REPORT IS FOR UNKNOWN CMF SCREWS. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923864 UNK - SCREWS: CMF SCREW, FIXATION, BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention