BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: LCP

    MDR report key: 25220059 · Received May 19, 2026

    Report

    Report Number
    8030965-2026-04730
    Event Type
    Injury
    Date Received
    May 19, 2026
    Date of Event
    January 1, 2025
    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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: 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: DR PRASHANT KUMAR SHARMA1, DR. SAI KIRAN JUTTIGA2*, DR. SANJAY DEV3, DR. J. JERIN TAMIL VALAN4, DR. RIJIN PLASIS5 FUNCTIONAL OUTCOME OF ABP OSTEOSYNTHESIS FOR HUMERUS MID-THIRD DIAPHYSEAL FRACTURES USING THE MIPPO TECHNIQUE: A HOSPITAL-BASED PROSPECTIVE FOLLOW-UP STUDY DOI: 10.53555/5V613C62 PUBMED CITE NOT AVAILABLE. OBJECTIVE/METHODS/STUDY DATA: THIS STUDY EVALUATES THE CLINICAL AND FUNCTIONAL OUTCOMES OF ANTERIOR BRIDGE PLATING (ABP) USING THE MIPPO TECHNIQUE. THIS WAS A HOSPITAL-BASED PROSPECTIVE FOLLOW-UP STUDY CONDUCTED IN THE DEPARTMENT OF ORTHOPAEDICS AT A TERTIARY CARE CENTRE LOCATED IN CENTRAL INDIA. THE STUDY SPANNED THREE YEARS, FROM (B)(6) 2021 TO (B)(6) 2023. A TOTAL OF 48 PATIENTS (MALE=32/FEMALE=12) WITH CLOSED COMMINUTED OR NON-COMMINUTED MID SHAFT HUMERAL FRACTURES WERE TREATED USING A 4.5 MM LOCKING COMPRESSION PLATE (LCP) VIA THE MIPPO APPROACH. THE MEAN AGE WAS 34.20 YEARS, WITH A RANGE OF 19 TO 51 YEARS. FOUR PATIENTS WERE LOST TO FOLLOW-UP, AND 44 PATIENTS COMPLETED THE STUDY. THE MEAN TIME TO FRACTURE UNION WAS 13.63 WEEKS. EACH CASE WAS MANAGED USING THE MINIMALLY INVASIVE PERCUTANEOUS PLATE OSTEOSYNTHESIS (MIPO) TECHNIQUE WITH A 4.5 MM LOCKING COMPRESSION PLATE (LCP). 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: (B)(4). (N=1) NON-UNION AT 10 WEEKS; MANAGED SUCCESSFULLY WITH BONE MARROW ASPIRATE GRAFTING, LEADING TO UNION BY 19 WEEKS (N=2) SUPERFICIAL SURGICAL SITE INFECTIONS; WERE EFFECTIVELY MANAGED WITH THOROUGH IRRIGATION, LOCAL DEBRIDEMENT, AND A COURSE OF INTRAVENOUS ANTIBIOTICS, RESULTING IN COMPLETE RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465632 UNK - CONSTRUCTS: LCP PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1