BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - PLATES: LCP

    MDR report key: 25123663 · Received May 8, 2026

    Report

    Report Number
    8030965-2026-04406
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    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 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: LIU CH, TSAI PJ, CHEN IJ, LAI PJ, LAI CY. INTRAOPERATIVE EVALUATION OF ROTATIONAL ALIGNMENT IN MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS FOR HUMERAL SHAFT FRACTURES USING COMBINED FLUOROSCOPIC AND ENDOSCOPIC ASSISTANCE: SURGICAL TECHNIQUE, CLINICAL OUTCOMES, AND LITERATURE REVIEW. ARCH ORTHOP TRAUMA SURG. 2026 FEB 2;146(1):49. DOI: 10.1007/S00402-025-06170-7. PMID: 41627520; PMCID: PMC12864267. OBJECTIVE/METHODS/STUDY DATA: THIS STUDY DESCRIBES AN INTRAOPERATIVE EVALUATION TECHNIQUE USING COMBINED FLUOROSCOPIC AND ENDOSCOPIC ASSISTANCE TO IMPROVE THE PRECISION AND OBJECTIVITY OF ROTATIONAL CORRECTION DURING MIPO. FROM SEPTEMBER 2019 TO JUNE 2023, TWENTY ADULT PATIENTS (13 MALES AND 7 FEMALES; MEAN AGE, 39.8 YEARS; RANGE, 18¿71) WITH SIMPLE TRANSVERSE OR WEDGE-TYPE MIDSHAFT HUMERAL FRACTURES (AO/OTA TYPE A OR B) WHO UNDERWENT MIPO FIXATION WERE RETROSPECTIVELY REVIEWED. ALL PROCEDURES USING FLUOROSCOPIC AND ENDOSCOPIC ASSISTANCE WERE PERFORMED BY A SINGLE ORTHOPEDIC SURGEON EXPERIENCED IN BOTH TRAUMA AND ARTHROSCOPIC SURGERY. 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: LCP (QTY 4): -(N=2) IATROGENIC FRACTURES; NO TREATMENT REPORTED -(N=2) DELAYED BONY UNION; NO TREATMENT REPORTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - PLATES: LCP (QTY 2): -(N=2) MILD PLATE MALPOSITIONING, WITH THE DISTAL PLATE SEGMENT SLIGHTLY MEDIALIZED BUT REMAINING STABLE; NO REVISION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138443 UNK - PLATES: LCP PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1