BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: EX-FIX

    MDR report key: 11642929 · Received April 9, 2021

    Report

    Report Number
    8030965-2021-02766
    Event Type
    Injury
    Date Received
    April 9, 2021
    Report Date
    March 12, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    NDK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN EXTERNAL FIXATION CONSTRUCT/UNKNOWN LOT. PART AND LOT NUMBER 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. 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. 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: ATHAR MS, ASHWOOD N, AEREALIS G, BAIN GI, (2018), IS EXTERNAL FIXATION A BETTER WAY THAN PLASTER TO SUPPLEMENT K-WIRES IN NON-COMMINUTED DISTAL RADIUS FRACTURES?, POSTGRAD MED J 2018, VOLUME 94, PAGE 20-24, (UNITED KINGDOM) IN THIS PROSPECTIVE RANDOMIZED INDEPENDENT STUDY, A COMPARISON BETWEEN THE TECHNIQUES OF KIRSCHNER WIRE (K-WIRE) FIXATION WITH PLASTER AND K-WIRE FIXATION WITH EXTERNAL FIXATION (EX-FIX) WAS UNDERTAKEN TO ASSESS WHICH TREATMENT MODALITY GIVES BETTER RESULTS IN PATIENTS WITH DISTAL RADIUS FRACTURE FRYKMAN VII AND VIII WITH NO METAPHYSEAL COMMINUTION. A TOTAL OF 51 PATIENTS WHO UNDERWENT FIXATION FOR DISTAL RADIUS FRACTURE WERE INCLUDED IN THE STUDY. THESE PATIENTS WERE RANDOMIZED INTO 2 GROUPS: 24 PATIENTS WERE TREATED WITH K-WIRE AND SPANNING UNKNOWN AO EX-FIX EXTERNAL FIXATOR SUPPLEMENTATION AND 27 PATIENTS WERE TREATED WITH K-WIRES AND PLASTER. THE UNKNOWN AO EX-FIX EXTERNAL FIXATOR WAS NOT USED AS A REDUCTION TOOL OR AS A DISTRACTION DEVICE BUT AS A NEUTRALIZATION DEVICE. PATIENTS WERE PROSPECTIVELY MONITORED FOLLOWING THE OPERATION WITH A MINIMUM FOLLOW-UP OF 1 YEAR. MEASUREMENT OF RANGE OF MOTION WAS OBTAINED AFTER SURGERY. VISUAL ANALOGUE SCALE (VAS) SCORES FOR PAIN AND SATISFACTION LEVELS WERE ALSO RECORDED. COMPLICATIONS WERE REPORTED AS FOLLOWS: UNKNOWN PATIENTS HAD PAIN. UNKNOWN PATIENTS HAD REDUCED RANGE OF MOTION. 3 PATIENTS WERE LOST TO FOLLOW-UP BECAUSE OF DEATH. THIS REPORT IS FOR THE UNKNOWN AO EX-FIX EXTERNAL FIXATOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539704 UNK - CONSTRUCTS: EX-FIX SYSTEM, EXTERNAL FIXATOR (WITH METALLIC INVASIVE COMPONENTS) NDK SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention