BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: LOCKING: CMF

    MDR report key: 11657446 · Received April 13, 2021

    Report

    Report Number
    8030965-2021-02841
    Event Type
    Injury
    Date Received
    April 13, 2021
    Report Date
    March 23, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    MQN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN CRANIOFACIAL RIGID EXTERNAL DEVICE- CMF LOCKING SCREW/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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: IANNETTI, G. ET AL. (2012), LE FORT III EXTERNAL MIDFACE DISTRACTION: SURGICAL OUTCOMES AND SKELETAL STABILITY, JOURNAL OF CRANIOFACIAL SURGERY, VOL. 23, PAGES 896-900 (ITALY). THIS RETROSPECTIVE STUDY EXAMINED THE STABILITY AND GROWTH OF THE MIDFACE IN 8 OF 14 PATIENTS WITH CRANIOFACIAL DYSOSTOSIS WHO UNDERWENT LE FORT III MIDFACE ADVANCEMENT USING THE RIGID EXTERNAL DISTRACTION DEVICE IN OUR DEPARTMENT. BETWEEN 2000 AND 2009, A TOTAL OF 8 PATIENTS UNDERWENT LE FORT III OSTEOTOMY WITH MIDFACE ADVANCEMENT USING A RIGID EXTERNAL DISTRACTION DEVICE (SYNTHES). THERE WERE 5 MALES AND 3 FEMALES WITH A MEAN AGE AT THE TIME OF THE PROCEDURE OF 8.6 YEARS, AND ALL THE PATIENTS HAD AT LEAST 1 YEAR OF FOLLOW-UP AFTER DISTRACTION. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 2 PATIENTS HAD PIN SITE INFECTIONS AT THE CRANIAL LOCK SCREWS. THESE CASES WERE SUCCESSFULLY TREATED WITH LOCAL CARE OF THE WOUNDS AND ORAL ANTIBIOTICS. 4 PATIENTS EXPERIENCED CRANIAL LOCK SCREW LOOSENING, WHICH REQUIRED TIGHTENING DURING ACTIVATION WITH LIMITED DISCOMFORT FOR THE PATIENTS. 1 PATIENT HAD 1 OF THE WIRES FOR TRANSCUTANEOUS TRACTION BROKE DURING CONSOLIDATION AND WAS SUBSTITUTED. 2 PATIENTS LAMENTED MINOR DISCOMFORT DUE TO TRACTION IN THE LAST ACTIVATION PHASES. THIS REPORT IS FOR AN UNKNOWN SYNTHES CRANIOFACIAL RIGID EXTERNAL DEVICE- CMF LOCKING SCREW. IT CAPTURES THE REPORTED 4 PATIENTS WHO HAD CRANIAL LOCK SCREW LOOSENING. THIS IS REPORT 7 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555506 UNK - SCREWS: LOCKING: CMF EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR MQN SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention