BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: VA-LCP DISTAL RADIUS PLATE/SCREWS

    MDR report key: 21776945 · Received April 4, 2025

    Report

    Report Number
    8030965-2025-03205
    Event Type
    Injury
    Date Received
    April 4, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. H3, H6: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, (01)GTIN IS NOT AVAILABLE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: TEGELS JJW, THEUNISSEN JEM, DE LOOS ER, MEESTERS B, BOONEN B, VAN VUGT R. THE RELATIONSHIP BETWEEN PLATE PROMINENCE AND NEED FOR REMOVAL AFTER VOLAR PLATE OSTEOSYNTHESIS OF DISTAL RADIUS FRACTURES. EUR J TRAUMA EMERG SURG. 2023 OCT;49(5):2105-2111. DOI: 10.1007/S00068-023-02311-Y. EPUB 2023 JUL 13. PMID: 37439860. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS RETROSPECTIVE COHORT STUDY IS TO ASSESS THE INCIDENCE OF PLATE-RELATED COMPLICATIONS AND THE NEED FOR PLATE REMOVAL AFTER VOLAR PLATE OSTEOSYNTHESIS OF THE DISTAL RADIUS IN RELATION TO SOONG CLASSIFICATION. BETWEEN JANUARY 2017 UNTIL JUNE 2019, A TOTAL OF 336 PATIENTS (81 MALE AND 255 FEMALE) WITH A MEAN AGE OF 62 WERE INCLUDED IN THE STUDY. THESE PATIENTS WERE TREATED WITH VARIABLE ANGLE LCP DISTAL RADIUS SYSTEM (DEPUY SYNTHES, AMERSFOORT, THE NETHERLANDS). OF THESE, 319 PATIENTS WERE TREATED SOLELY WITH VOLAR LOCKING PLATES AND 17 WERE TREATED WITH ADDITIONAL DORSAL PLATES. FOLLOW-UP WERE UNKNOWN. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SYNTHES VA-LCP DISTAL RADIUS SYSTEM. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: VA-LCP DISTAL RADIUS PLATE/SCREWS (QTY 53). 22 PATIENTS HAD REPORTED PAIN. 6 PATIENTS HAD REDUCED FUNCTIONALITY. 1 PATIENT HAD DISCOMFORT. 4 PATIENTS HAD FLEXOR TENDON RUPTURE. 2 PATIENTS HAD EXTENSOR TENDON RUPTURE. 4 PATIENTS HAD TENDON IRRITATION. 4 PATIENTS HAD INTRA-ARTICULAR SCREWS. 3 PATIENTS HAD FRACTURE DISLOCATION. 1 PATIENT HAD CARPAL TUNNEL SYNDROME. 7 PATIENTS HAD UNKNOWN REMOVAL INDICATION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - PLATES: VA-LCP DISTAL RADIUS (QTY 4). 4 PATIENT HAD PRECAUTION DUE TO PLATE POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048653 UNK - CONSTRUCTS: VA-LCP DISTAL RADIUS PLATE/SCREWS PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention