BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PLATE/SCREWS

    MDR report key: 10541262 · Received September 16, 2020

    Report

    Report Number
    8030965-2020-07066
    Event Type
    Injury
    Date Received
    September 16, 2020
    Report Date
    August 20, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE PATIENT INVOLVED. IMPLANTATION DATE UNKNOWN. THIS REPORT IS FOR AN UNK - CONSTRUCTS: 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 AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. (B)(4). 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

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: ZHANG Y., ET AL (2019) EFFICACY AND PROGNOSIS OF 3D PRINTING TECHNOLOGY IN TREATMENT OF HIGH-ENERGY TRANS-SYNDESMOTIC ANKLE FRACTURE DISLOCATION ¿ ¿LOG-SPLITTER¿ INJURY, MEDICAL SCIENCE MONITOR VOLUME 25 , PAGES 4233-4243 (CHINA). THIS RETROSPECTIVE STUDY AIMS TO COMPARE THE TRADITIONAL SURGERY WITH 3D PRINTING SURGERY IN THE TREATMENT OF LOG-SPLITTER INJURY AND EVALUATED THE PROGNOSIS. FROM JUNE 2011 TO DECEMBER 2016, A TOTAL OF 29 PATIENTS (17 MALES AND 12 FEMALES) WHO WERE DIAGNOSED WITH LOG SPLITTER INJURY WERE REVIEWED. PATIENTS WERE DIVIDED INTO ROUTINE GROUP (N=13) WITH 8 MALES AND 5 FEMALES WITH MEAN AGE OF 43.3±13.9 YEARS AND 3D PRINTING GROUP (N=16) WITH 9 MALES AND 7 FEMALES WITH MEAN AGE OF 44.5±13.5 YEARS BY RANDOM NUMBER TABLE METHOD AFTER ADMISSION, AND TREATED ACCORDING TO THE DIFFERENT SURGICAL METHODS. THE OPERATION FIRST FIXES THE FIBULA OR LATERAL MALLEOLUS, AND A 3.5-MM LOCKING COMPRESSION PLATE (LCP) OF VARYING LENGTH AND THE CORTICAL LOCKING SCREWS OF DIFFERENT SPECIFICATIONS (WEIGAO MED, INC., WEIHAI, CHINA).ALL PATIENTS WERE SUCCESSFULLY FOLLOWED UP FOR MORE THAN 12 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 2 PATIENTS OBTAINED FAIR PROGNOSIS, AND 1 PATIENT OBTAINED POOR PROGNOSIS IN 3D PRINTING GROUP. ONLY 13 PATIENTS IN THE 3D PRINTING GROUP OBTAINED ANATOMICAL REDUCTION. IN THE ROUTINE GROUP, ONLY 9 PATIENTS OBTAINED ANATOMICAL REDUCTION, 3 PATIENTS OBTAINED FAIR PROGNOSIS, AND 1 PATIENT OBTAINED POOR PROGNOSIS. 1 SUPERFICIAL INFECTION IN ROUTINE GROUP. 1 SUPERFICIAL INFECTION IN 3D PRINTING GROUP. 1 DELAYED FRACTURE UNION IN ROUTINE GROUP. 2 DELAYED FRACTURE UNION IN 3D PRINTING GROUP. 1 MALUNION IN ROUTINE GROUP. THIS REPORT IS FOR AN UNKNOWN SYNTHES 3.5-MM LOCKING COMPRESSION PLATE (LCP). THIS IS REPORT 1 OF 1 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005587 UNK - CONSTRUCTS: PLATE/SCREWS SCREW,FIXATION,BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention