BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNWON SCREW MATRIX MANDIBLE

    MDR report key: 13667987 · Received March 4, 2022

    Report

    Report Number
    8030965-2022-01373
    Event Type
    Malfunction
    Date Received
    March 4, 2022
    Date of Event
    February 2, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS FOR AN UNKNOWN SCREW/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN OSTEOTOMY OF THE MAXILLA DUE TO JAW DEFORMITY PERFORMED ON (B)(6) 2022. WHEN FIXING THE MAXILLA WITH THE MOJ SYSTEM, MULTIPLE LOCKING SCREWS FOR ANOTHER SYSTEM (MATRIX MANDABLE TRAUMA) WERE USED BY MISTAKE. A NURSE OPENED THE WRONG SCREWS, BUT THE SURGEON DID NOT NOTICE IT UNTIL THE MIDDLE OF THE PROCEDURE. AFTER INSERTING MULTIPLE SCREWS AND FIXING THEM, THE SURGEON NOTICED THAT THE USED SCREWS WERE WRONG. HOWEVER, THE SURGEON JUDGED THAT THERE WOULD BE NO PROBLEM WITH THE FIXATION, AND THE SCREWS WERE DEPLOYED AS THEY WERE. THE SURGERY WAS COMPLETED WITH NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) UNKNOWN SCREW MATRIX MANDIBLE. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1532968 UNKNWON SCREW MATRIX MANDIBLE SCREW,FIXATION,BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK - PLATES: MATRIXMANDIBLE| UNK - SCREWS: MATRIXMANDIBLE