BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PLATES: 2.4 MM VARIABLE ANGLE LCP VOLAR RIM DISTAL RADIUS PLATE

    MDR report key: 12565241 · Received October 1, 2021

    Report

    Report Number
    8030965-2021-08299
    Event Type
    Injury
    Date Received
    October 1, 2021
    Report Date
    September 3, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    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 2.4MM VARIABLE ANGLE LCP VOLAR RIM DISTAL RADIUS PLATE/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: BAI, X, LIU Z, WANG B, ET AL. (2021), SHEAR WAVE ELASTOGRAPHY (SWE) EVALUATION OF ASYMPTOMATIC FLEXOR POLLICIS LONGUS TENDON CONDITION AFTER VOLAR PLATE FIXATION FOR DISTAL RADIUS FRACTURE, INTERNATIONAL JOURNAL OF GENERAL MEDICINE, VOLUME 14, PAGES 187-193, (CHINA). THIS STUDY AIMED TO EVALUATE ASYMPTOMATIC FLEXOR POLLICIS LONGUS TENDON CONDITION AFTER VOLAR PLATE FIXATION FOR DISTAL RADIUS FRACTURE USING SHEAR WAVE ELASTOGRAPHY. FROM 2016¿2019, 36 PATIENTS WITH DISTAL RADIUS FRACTURES WHO UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION WITH THE RADIUS DISTAL VOLAR LOCKING PLATE WERE INCLUDED IN THE STUDY. THERE WERE 11 MALES AND 25 FEMALES WITH A MEAN AGE OF 62.8 YEARS (RANGE=52¿73 YEARS). ALL INVOLVED PATIENTS UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION WITH THE UNKNOWN SYNTHES 2.4MM VARIABLE ANGLE LCP VOLAR RIM DISTAL RADIUS PLATE. ULTRASONOGRAPHY WAS USED TO MEASURE THE FLEXOR POLLICIS LONGUS TENDON DISTANCE TO THE VOLAR PLATE IN THE INVOLVED WRISTS, AND THE THICKNESS OF THE FLEXOR POLLICIS LONGUS TENDON IN THE INVOLVED WRISTS WAS MEASURED ON SHEAR WAVE ELASTOGRAPH SONOGRAMS TAKEN 12 MONTHS POSTOPERATIVELY. COMPLICATIONS WERE REPORTED AS FOLLOWS: UNKNOWN PATIENTS HAD ASYMPTOMATIC TENDON INJURY. 17 PATIENTS HAD SOONG GRADE 1 VOLAR PLATE PROMINENCE. 7 PATIENTS HAD SOONG GRADE2 VOLAR PLATE PROMINENCE. THIS REPORT IS FOR THE UNKNOWN SYNTHES 2.4MM VARIABLE ANGLE LCP VOLAR RIM DISTAL RADIUS PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1463178 UNK - PLATES: 2.4 MM VARIABLE ANGLE LCP VOLAR RIM DISTAL RADIUS PLATE PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention