BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: NARROW LCP

    MDR report key: 25217793 · Received May 19, 2026

    Report

    Report Number
    8030965-2026-04712
    Event Type
    Injury
    Date Received
    May 19, 2026
    Date of Event
    September 16, 2024
    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: SUGUMAR N, SATHIYASEELAN N, PURUSHOTHAMAN JR, NATARAJAN S. ASSESSING FUNCTIONAL AND RADIOLOGICAL OUTCOMES: OPEN REDUCTION AND INTERNAL FIXATION VS. MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS FOR HUMERUS SHAFT FRACTURES - A PROSPECTIVE COMPARATIVE STUDY. INT ORTHOP. 2024 NOV;48(11):2979-2991. DOI: 10.1007/S00264-024-06307-0. EPUB 2024 SEP 16. PMID: 39285022. OBJECTIVE/METHODS/STUDY DATA: THE PURPOSE OF THE STUDY IS TO ANALYSE AND COMPARE THE FUNCTIONAL AND RADIOLOGICAL OUTCOME OF DIFFERENT METHODS OF SURGICAL MANAGEMENT OF HUMERUS SHAFT FRACTURES IN 30 PATIENTS TREATED BY CONVENTIONAL OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OR MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS (MIPO). BETWEEN NOVEMBER 2018 TO MAY 2020, PATIENTS WITH A CLINICAL AND RADIOLOGICAL DIAGNOSIS OF SHAFT OF HUMERUS FRACTURES WERE INCLUDED. 30 PATIENTS WERE DIVIDED INTO TWO EQUAL GROUPS-ORIF AND MIPO. THE OVERALL MEAN AND STANDARD DEVIATION OF AGE OF ALL 30 PATIENTS YEARS IS 44.4 ± 18.2. THE MAXIMUM PROPORTION OF PATIENTS WERE MALE (53.3%). 46.6% OF PATIENTS WERE FEMALE. IN THE MIPO GROUP, LONG 10-HOLED TO 12-HOLED NARROW LCP WITH 3.5 MM CORTICAL SCREWS WERE USED FOR FIXATION. IN THE ORIF GROUP, TEN PATIENTS UNDERWENT SURGERY BY A POSTERIOR APPROACH AND AN ANTEROLATERAL APPROACH WAS DONE FOR THE REMAINING FIVE PATIENTS. AMONG THE 15 PATIENTS OF THE ORIF GROUP, BROAD DCP WITH 4.5 MM CORTICAL SCREWS WERE USED FOR NINE PATIENTS AND NARROW LCP WITH 3.5 MM CORTICAL SCREWS WERE USED FOR 6 PATIENTS. ALL PATIENTS WERE FOLLOWED UP FOR AT LEAST SIX MONTHS TO A MAXIMUM OF TWO YEARS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES NARROW LCP & BROAD DCP. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: NARROW LCP (QTY (B)(4): (N=1) FRACTURE NON-UNION; REVISION SURGERY OF PLATING WITH BONE GRAFTING (N=2) PERI-IMPLANT FRACTURE; UNDERWENT REVISION SURGERY. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: PLATE/SCREWS (QTY (B)(4): (N=3) FRACTURE NON-UNION; REVISION SURGERY OF PLATING WITH BONE GRAFTING (N=1) PERI-IMPLANT FRACTURE; UNDERWENT REVISION SURGERY (N=2) SECONDARY RADIAL NERVE PALSY; ROUTINE POST-OP PROTOCOL, MOBILIZATION AND PHYSIOTHERAPY WERE DONE WITH DYNAMIC COCK-UP SPLINT. THE NERVE FUNCTION EVENTUALLY RETURNED WITHIN TWO TO THREE MONTHS FROM THE DATE OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523363 UNK - CONSTRUCTS: NARROW LCP PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1