BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: NARROW LCP

    MDR report key: 25152425 · Received May 12, 2026

    Report

    Report Number
    8030965-2026-04524
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    August 10, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH 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. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: JITPRAPAIKULSARN S, SENGPANICH P, RUNGSAKAOLERT P, SUKHA K, REINGRITTHA P, GROMPRASIT A. CONCURRENT PLATE FIXATION AND PEDICLED FLAP COVERAGE FOR OPEN FRACTURES COMPLICATED BY SOFT TISSUE LOSS OF THE TIBIA IN PEDIATRIC COHORT: A CLINICAL SERIES. EUR J ORTHOP SURG TRAUMATOL. 2024 AUG;34(6):3241-3250. DOI: 10.1007/S00590-024-04059-6. EPUB 2024 AUG 10. PMID: 39127835. OBJECTIVE/METHODS/STUDY DATA: THE PURPOSES OF THE PRESENT STUDY WERE TO DELINEATE THE TREATMENT PROTOCOL OF CONCURRENT PLATE FIXATION AND PEDICLED F LAP COVERAGE IN PEDIATRIC PATIENTS WHO WERE DIAGNOSED WITH OPEN TIBIAL FRACTURES ACCOMPANIED BY SOFT TISSUE LOSS AND TO RETROSPECTIVELY REVIEW FLAP-RELATED COMPLICATIONS, PERI OPERATIVE COMPLICATIONS, FRACTURE CONSOLIDATION AND CLINICAL RESULTS BY OBJECTIVE SCORING SYSTEM. BETWEEN FEBRUARY 2015 AND JANUARY 2022, A CASE SERIES OF 25 OPEN TIBIAL FRACTURES ACCOMPANIED BY SOFT TISSUE LOSS WAS TREATED BY SINGLE-STAGE PLATE FIXATION AND PEDICLE FLAP RECONSTRUCTION AT A TRAUMA UNIT IN AN ORTHOPEDIC TERTIARY CARE INSTITUTE WITH 16MALES AND 9FEMALES. A MEAN FOLLOW-UP TIME WAS 30 MONTHS (RANGE 24¿36). THE STRAIGHT PLATE WAS UTILIZED FOR DIAPHYSEAL FRACTURES; MEANWHILE, PRECONTOURED LCP WAS UTILIZED FOR METAPHYSEAL FRACTURES. A 3.5 MM LCP WAS APPLIED IN SMALL DIAMETER BONE; MEANWHILE, A 5.0 MM LCP WAS APPLIED IN LARGER BONE. AT LEAST 3 SCREWS CAPTURING 6 CORTEXES IN EACH FRAGMENT WERE REQUIRED. ACCORDING TO THE TYPE OF PLATE, NARROW LCP WAS APPLIED IN 8, 3.5 MM PRECON TOURED LCP IN 10, 5.0 MM PRECONTOURED IN 2 AND DOUBLE LCP IN 5. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH LCP. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: NARROW LCP (QTY 1): ¿ PATIENT # 3: A 15-YEAR-OLD MALE HAD AN IMPLANT IRRITATION; REQUIRED ADDITIONAL OPERATIONS TO REMOVE THE PLATE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: 3.5 MM LCP PLATE/SCREWS (QTY 2): ¿ PATIENT # 12: A 10-YEAR-OLD MALE HAD AN INFECTED PLATE; UNDERWENT IMPLANT REMOVAL. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: NARROW LCP (QTY 1): ¿ PATIENT # 14: A 12-YEAR-OLD MALE HAD AN IMPLANT IRRITATION; REQUIRED ADDITIONAL OPERATIONS TO REMOVE THE PLATE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: 3.5 MM LCP PLATE/SCREWS & UNK - CONSTRUCTS: LCP (QTY 1). ¿ PATIENT # 16: A 14-YEAR-OLD FEMALE HAD AN INFECTED PLATE; UNDERWENT IMPLANT REMOVAL. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: 3.5 MM LCP PLATE/SCREWS (QTY 1): ¿ PATIENT # 17: A 7-YEAR-OLD FEMALE HAD AN IMPLANT IRRITATION; REQUIRED ADDITIONAL OPERATIONS TO REMOVE THE PLATE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: LCP (QTY 1). ¿ PATIENT # 18: 14-YEAR-OLD MALE HAD AN IMPLANT IRRITATION; REQUIRED ADDITIONAL OPERATIONS TO REMOVE THE PLATE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: 3.5 MM LCP PLATE/SCREWS (QTY 2): PATIENT # 24: A 15-YEAR-OLD MALE HAD AN IMPLANT IRRITATION; REQUIRED ADDITIONAL OPERATIONS TO REMOVE THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217363 UNK - CONSTRUCTS: NARROW LCP PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1