BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 21784941 · Received April 7, 2025

    Report

    Report Number
    8030965-2025-03243
    Event Type
    Injury
    Date Received
    April 7, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHARMACIST
    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. H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. INVESTIGATION SUMMARY: 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 IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: SEOK HG, PARK WT, PARK SJ, PARK SG. SMALL VOLAR FRAGMENT IN THE LUNATE FOSSA LEADS TO VOLAR TILT LOSS AFTER VOLAR PLATE FIXATION FOR AO/OTA TYPE-C DISTAL RADIUS FRACTURE. HAND SURG REHABIL. 2024 APR;43(2):101674. DOI: 10.1016/J.HANSUR.2024.101674. EPUB 2024 FEB 29. PMID: 38431044. OBJECTIVE/METHODS/STUDY DATA: THE PURPOSE OF THE STUDY WAS TO ELUCIDATE THE RELATIONSHIP BETWEEN MALUNION WITH DEFORMITY AND THE SIZE OF THE VOLAR FRAGMENT IN AO/ OTA TYPE C DRF, BY MEASURING MORE ACCURATE RADIOLOGIC PARAMETERS ON PREOPERATIVE CT: ANTEROPOSTERIOR LENGTH, HEIGHT AND TEARDROP ANGLE. BETWEEN MARCH 2014 AND JULY 2022, A TOTAL OF 163 PATIENTS (74 MALE AND 89 FEMALE) WITH THE MEAN AGE OF 61.3 ± 12.8 YEARS (RANGE, 39-70 YEARS) WERE INCLUDED IN THE STUDY. THESE PATIENTS WERE TREATED WITH DISTAL RADIUS LOCKING PLATE (VA-LCP DISTAL RADIUS SYSTEM, SYNTHES, SWITZERLAND). THE FOLLOW-UP PERIOD WAS 23.2 ± 9.7 MONTHS (RANGE, 13¿38 MONTHS). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) 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: 17). 12 CASES OF VOLAR TILT LOSS (VTL). NO INTERVENTION PROVIDED. 1 VOLAR FRAGMENT DISPLACEMENT. NO INTERVENTION PROVIDED. 4 CASES OF REVISION OPERATIONS WERE PERFORMED. SURGICAL TREATMENT WAS RECOMMENDED FOR THE OTHER PATIENTS BUT DUE TO ADVANCED AGE OR COMORBIDITIES, THEY DECLINED AND WERE PLACED UNDER OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654322 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