BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: LCP

    MDR report key: 25182531 · Received May 15, 2026

    Report

    Report Number
    8030965-2026-04610
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    September 30, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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: NISHANT JAJEE, SANDEEP SRIRAM, NAGESH M INGINSHETTY, G. RAJESH REDDY, RADHA BAWAGE, FUNCTIONAL OUTCOME OF TIBIAL FRACTURES IN CHILDREN TREATED BY SUPRACUTANEOUS LOCKING PLATES: INTERNATIONAL JOURNAL OF PHARMACEUTICAL AND CLINICAL RESEARCH 2023; 15(10); 812-816 (PUBMED CITATION NOT AVAILABLE) OBJECTIVE/METHODS/STUDY DATA: THIS IS A PROSPECTIVE OBSERVATIONAL STUDY, THE PURPOSE OF THE STUDY IS TO EVALUATE THE FUNCTIONAL AND RADIOLOGICAL OUTCOME RESULTS OF CLOSED REDUCTION OR OPEN REDUCTION OF TIBIAL FRACTURES AND FIXATION USING LOCKING PLATE AS SUPRA CUTANEOUS EXTERNAL FIXATOR IN CHILDREN. BETWEEN JUNE 2018 AND MAY 2019, 32 CHILDREN WITH TIBIAL FRACTURES HAVING SOFT TISSUE INJURY UNDERWENT EXTERNAL FIXATION WITH LOCKING PLATES. THERE WERE 22 MALE AND 10 FEMALE CHILDREN WITH MEAN AGE OF 10.5 YEARS (RANGE 6 TO 15 YEARS). MEAN FOLLOW-UP WAS 24 WEEKS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES, LOCKING PLATES(LCP) ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: LCP (QTY 3) (N=1) CASE OF SCREW SITE INFECTION, REQUIRES WOUND DEBRIDEMENT. (N=1) CASE OF DELAYED UNION, REQUIRES WOUND DEBRIDEMENT. (N=1) CASE OF GAP NON-UNION, REQUIRES BONE GRAFTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562100 UNK - CONSTRUCTS: LCP PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1