BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: MATRIXMIDFACE

    MDR report key: 12351165 · Received August 20, 2021

    Report

    Report Number
    8030965-2021-07030
    Event Type
    Injury
    Date Received
    August 20, 2021
    Report Date
    July 24, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN MATRIX ORBITAL 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. 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: ZONG C., ET AL (2021) A RETROSPECTIVE STUDY TO COMPARE THE TREATMENT OUTCOMES WITH AND WITHOUT SURGICAL NAVIGATION FOR FRACTURE OF THE ORBITAL WALL, CHINESE JOURNAL OF TRAUMATOLOGY VOLUME 24 , PAGES 11-17 (CHINA) HTTPS://DOI.ORG/10.1016/J.CJTEE.2020.10.002. THIS STUDY AIMS TO ASSESS THE ACCURACY AND TREATMENT OUTCOMES OF COMPUTER-ASSISTED SURGICAL NAVIGATION SYSTEM (CASNS) IN THE REPAIR OF A UNILATERAL OWF BY DIRECT COMPARISON WITH THE CONVENTIONAL METHOD. FROM 2014 TO 2017, PATIENTS ADMITTED TO THE DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY WITHIN THE SCHOOL OF STOMATOLOGY OF THE FOURTH MILITARY MEDICAL UNIVERSITY (XI¿AN, CHINA) FOR REPAIR OF UNILATERAL TRAUMATIC OWF WERE INCLUDED IN OUR STUDY. PATIENTS WERE DIVIDED INTO THE NAVIGATION GROUP (IN WHICH CASNS WAS USED) AND THE CONVENTIONAL GROUP (IN WHICH FREEHAND METHOD BASED ON THE SURGEON¿S EXPERIENCE WAS EMPLOYED. FORTY PATIENTS (25 MALES, 15 FEMALES) WERE TREATED USING A CASNS. THIRTY PATIENTS (24 MALES, 6 FEMALES) WERE TREATED IN THE CONVENTIONAL METHOD. THE AGE RANGED 18E56 YEARS IN THE NAVIGATION GROUP (MEAN 37.4 YEARS) AND 22E61 YEARS IN THE CONVENTIONAL GROUP (MEAN 40.6 YEARS). DURING THE PROCEDURE FOR INTRAOPERATIVE NAVIGATION FRACTURE AREA AND RELEASING THE TISSUE HERNIA, A TITANIUM ORBITAL PLATE (MATRIXMIDFACE PLATING SYSTEM, DEPUY SYNTHES, SWITZERLAND) WAS PLACED INTO THE ORBITAL CAVITY TO COVER THE BONY DEFECT AND TO REBUILD THE CURVE OF THE ORBITAL WALL. IN THE CONVENTIONAL GROUP THE IMPLANT (TITANIUM ORBITAL PLATE, DEPUY SYNTHES, SWITZERLAND) WAS PLACED IN THE ORBITAL CAVITY TO REPAIR THE FRACTURE. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: AFTER 6-MONTH FOLLOW-UP, ONE PATIENT HAD DIPLOPIA AND TWO PATIENTS COMPLAINED OF OBVIOUS ORBITAL ASYMMETRY AFTER ORBITAL WALL REPAIR IN THE NAVIGATION GROUP. IN THE CONVENTIONAL GROUP, TWO PATIENTS HAD PERSISTENT DIPLOPIA (ONE PATIENT ALSO HAD DYSFUNCTION OF OCULAR MOTILITY) AND FOUR PATIENTS COMPLAINED OF OBVIOUS ORBITAL ASYMMETRY. THE DISCREPANCY OF THE OCV IN THE AFFECTED SIDE BEFORE AND AFTER SURGERY (VREA) IN THE NAVIGATION GROUP WAS SIGNIFICANTLY HIGHER THAN THAT IN THE CONVENTIONAL GROUP (4.15 ± 1.78 VS. 2.72 ± 1.50, P ¼ 0.001). THE DISCREPANCY IN THE ABCES DISTANCE BEFORE AND AFTER SURGERY IN THE AFFECTED SIDE (DREA) WAS SIGNIFICANTLY HIGHER IN THE NAVIGATION GROUP ((3.51 ± 1.45) MM) THAN THAT IN THE CONVENTIONAL GROUP ((1.96 ± 0.82) MM) (P ¼ 0.028), WHICH INDICATED THAT GREATER CORRECTION OF ENOPHTHALMOS WAS ACHIEVED IN THE NAVIGATION GROUP. THIS REPORT IS FOR AN UNKNOWN SYNTHES TITANIUM ORBITAL MATRIXMIDFACE PLATING SYSTEM SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243823 UNK - SCREWS: MATRIXMIDFACE SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention