BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: LCP MEDIAL DISTAL TIBIA PLATE/SCREWS

    MDR report key: 24168414 · Received January 23, 2026

    Report

    Report Number
    8030965-2026-00816
    Event Type
    Injury
    Date Received
    January 23, 2026
    Date of Event
    June 19, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. 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

    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: ADDED: D4 CATALOG. 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: ERIVAN R, CAPUTO T, MONADJEMI S, PEREIRA B, DESCAMPS S, BOISGARD S, VILLATTE G. A COMPARISON OF MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS (MIPO) VERSUS OPEN REDUCTION AND INTERNAL FIXATION (ORIF) IN THE MANAGEMENT OF TIBIAL PILON FRACTURES: A PROSPECTIVE RANDOMIZED STUDY. ORTHOP TRAUMATOL SURG RES. 2025 NOV;111(7):104323. DOI: 10.1016/J.OTSR.2025.104323. EPUB 2025 JUN 19. PMID: 40543647. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS RETROSPECTIVE STUDY WAS TO COMPARE TWO SURGICAL PROCEDURES FOR THE TREATMENT OF TIBIAL PILON FRACTURES, I.E. MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS (MIPO) VS. OPEN REDUCTION AND INTERNAL FIXATION (ORIF), IN TERMS OF WOUND HEALING TIME, ANKLE SWELLING, CHANGE IN PAIN, FUNCTIONAL OUTCOMES AND COMPLICATIONS. BETWEEN NOVEMBER 2017 AND MAY 2023, A TOTAL OF 54 PATIENTS HOSPITALIZED FOR A TIBIAL PILON FRACTURE WITH CLOSED OR OPEN FRACTURE (CAUCHOIX OR GUSTILO TYPE I) RECEIVED RANDOMLY ORIF OR MIPO TREATMENT USING DISTAL TIBIAL LOCKING COMPRESSION PLATES OF 3.5 MM. MIPO GROUP (N = 25) THERE WERE 12 (46.15%) FEMALES AND 14 (53.85 %) MALES WITH THE MEAN AGE OF 53.14 ± 13.73 YEARS WHILE ORIF GROUP (N =26) HAS 9 (34.62%) FEMALES AND 17 (65.38%) MALES WITH THE MEAN AGE OF 48.91 ± 16.14 YEARS. ANTEROMEDIAL DISTAL TIBIAL LOCKING COMPRESSION PLATES (LCP; SYNTHES GMBH, SWITZERLAND) OF 3.5 MM WERE EMPLOYED IN BOTH GROUPS. THE MEAN FOLLOW UP WAS 9.2 ± 4.7 MONTHS. LOT, MODEL AND CATALOG NUMBERS ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SYNTHES ANTEROMEDIAL DISTAL TIBIAL LOCKING COMPRESSION PLATES (LCP). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: LCP MEDIAL DISTAL TIBIA PLATE/SCREWS (QTY 29): 11 PATIENTS HAD DEEP VENOUS THROMBOSIS; NO INTERVENTION WAS MENTIONED. 8 PATIENTS HAD INFECTION; NO INTERVENTION WAS MENTIONED. 5 PATIENTS HAD PSEUDOARTHROSIS REQUIRING REOPERATION. 5 PATIENTS HAD WOUND COMPLICATION; NO INTERVENTION WAS MENTIONED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - PLATES: LCP MEDIAL DISTAL TIBIAL PLATE (QTY 4): 4 PATIENTS HAD IMPLANT BREAKAGE; NO INTERVENTION WAS MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224315 UNK - CONSTRUCTS: LCP MEDIAL DISTAL TIBIA PLATE/SCREWS PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention