BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PLATE/SCREWS

    MDR report key: 10390262 · Received August 11, 2020

    Report

    Report Number
    8030965-2020-05849
    Event Type
    Injury
    Date Received
    August 11, 2020
    Report Date
    July 20, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS 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

    510K: THIS REPORT IS FOR AN UNKNOWN VOLAR LOCKING PLATING (VLP) CONSTRUCT/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. 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: ZHOU Y., ET AL COMPARISON OF RADIOGRAPHIC AND FUNCTIONAL RESULTS OF DIE-PUNCH FRACTURE OF DISTAL RADIUS BETWEEN VOLAR LOCKING PLATING (VLP) AND EXTERNAL FIXATION (EF), JOURNAL OF ORTHOPAEDIC SURGERY AND RESEARCH VOLUME 14, PAGES 1-7 (CHINA) HTTPS://DOI.ORG/10.1186/S13018-019-1442-0. THIS RETROSPECTIVE STUDY AIMS TO COMPARE THE EXTERNAL FIXATOR AND THE TRADITIONAL VLP FIXATION FOR TREATMENT OF DIE-PUNCH FRACTURES, WITH REGARD TO RADIOLOGICAL PARAMETERS (VOLAR TILT, RADIAL INCLINATION, ARTICULAR STEP-OFF, ULNAR VARIANCE), FUNCTIONAL OUTCOMES (WRIST MOBILITY, GRIP STRENGTH), AND THE OVERALL FUNCTIONAL ASSESSMENT USING DISABILITIES OF THE ARM, SHOULDER, AND HAND (DASH) AND GARTLAND¿WERLEY SCORING SYSTEMS. BETWEEN JANUARY 2015 AND JUNE 2018, A TOTAL OF 87 PATIENTS DIAGNOSED AS DIEPUNCH FRACTURE OF THE DISTAL RADIUS WERE INCLUDED IN THIS STUDY. THERE WERE 63 PATIENTS TREATED BY T-SHAPE LOCKING PLATE (SYNTHES, SHANGHAI; WEGO, SHANDONG, CHINA) VLP, INCLUDING 25 MEN AND 38 WOMEN, WITH AVERAGE AGE OF 52 YEARS (SD, 15; RANGE, 18 TO 73 YEARS). IN EXTERNAL FIXATOR GROUP, THERE WERE 24 PATIENTS, INCLUDING NINE MEN AND 15 WOMEN, WITH AVERAGE AGE OF 44 YEARS (SD, 15; RANGE, 18 TO 66 YEARS) THE EXTERNAL FIXATOR (STRYKER TRAUMA CORPORATION, SWISS) WAS USED. THREE WEEKS, 6 WEEKS, AND 3 MONTHS AFTER SURGERY, REGULAR X-RAY CHECK WAS PERFORMED AND BONE UNION STATUS WAS EVALUATED. AFTER 6 WEEKS, KIRSCHNER WIRE AND THE EXTERNAL FIXATOR WERE REMOVED AND WRIST EXERCISES WERE PERFORMED TO INCREASE THE MOTION RANGE OF THE OPERATED WRIST. THE FOLLOW-UP TIME WAS 15.6 MONTHS IN AVERAGE (12 TO 42 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: TWO PATIENTS IN VLP GROUP DEVELOPED COMPLEX REGIONAL PAIN SYNDROME TYPE I (CRPS), WHICH REQUIRED LONG-TERM PHYSIOTHERAPY. IN VLP GROUP, TWO PATIENTS HAD CARPAL TUNNEL SYNDROME, WHICH RESOLVED WITH IMMEDIATE CARPAL TUNNEL DECOMPRESSION OR LONGTERM PHYSIOTHERAPY. TENDON COMPLICATIONS INCLUDING TENDONITIS OR TENDON CONTRACTURES OCCURRED IN THE VLP GROUP. 1 NEUROPATHY OR NERVE INJURY. 3 TENDON COMPLICATION. 1 HARDWARE FAILURE. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN SYNTHES T-SHAPE LOCKING PLATE VLP CONSTRUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854511 UNK - CONSTRUCTS: PLATE/SCREWS PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention