BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: PHILOS

    MDR report key: 24899137 · Received April 16, 2026

    Report

    Report Number
    8030965-2026-03541
    Event Type
    Injury
    Date Received
    April 16, 2026
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. 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: HUSTIN L, AMOUYEL T, SAAB M, CHANTELOT C. COMPARISON OF CLASSICAL AND MINIMALLY INVASIVE SUPEROLATERAL APPROACH FOR RECONSTRUCTION OF PROXIMAL HUMERUS FRACTURES WITH LOCKING PLATES. INJURY. 2024 JUN;55 SUPPL 1:111405. DOI: 10.1016/J.INJURY.2024.111405. EPUB 2024 JUL 26. PMID: 39069348. OBJECTIVE/METHODS/STUDY DATA: THE MAIN OBJECTIVE OF THIS RETROSPECTIVE MONOCENTRIC COMPARATIVE MULTI-OPERATOR STUDY WAS TO COMPARE THE OUTCOMES AND COMPLICATIONS AFTER LOCKING PLATE OSTEOSYNTHESIS OF PROXIMAL HUMERUS (PH) FRACTURES WITH THE CONVENTIONAL AND MINIMALLY INVASIVE (MI) SUPEROLATERAL APPROACHES. ADULT PATIENTS ON WHOM PHILOS® LOCKING PLATE OSTEOSYNTHESIS WAS PERFORMED BETWEEN 2007 AND 2015 WERE INCLUDED. OF THE 71 RECONTACTED PATIENTS ¿ 43 WOMEN AND 28 MEN ¿ 27 PATIENTS WERE OPERATED ON WITH A MI APPROACH AND 44 WITH A CONVENTIONAL APPROACH. THE MEAN FOLLOW-UP WAS 42.6 ± 15.3 MONTHS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: PHILOS® (DEPUY-SYNTHES¿). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: PHILOS PLATE/SCREWS (QTY (B)(4): -(N=2) AXILLARY NERVE DAMAGE; ONE PATIENT HAD A SENSORY DEFICIT IN THE SHOULDER STUMP AND, DURING THE EMG, ONE PATIENT SHOWED SIGNS OF AN OLD INJURY AND WAS RECOVERING. -(N=7) ASEPTIC OSTEONECROSIS OF THE HUMERAL HEAD (ONHH); ONE HEMIARTHROPLASTY WAS PERFORMED ON 1 PATIENT DUE TO ONHH. -(N=14) OSTEOARTHRITIS; NO INTERVENTION REPORTED. -(N=16) MALUNION; NO INTERVENTION REPORTED. -(N=14) SUBACROMIAL IMPINGEMENT (SAI); NO INTERVENTION REPORTED. -(N=4) TYPE I COMPLEX REGIONAL PAIN SYNDROME (CRPS TYPE I); NO INTERVENTION REPORTED. -(N=7) TUBEROSITY LYSIS; NO INTERVENTION REPORTED. -(N=10) UNDERWENT REVISION SURGERY: THREE IMPLANT REMOVALS WERE PERFORMED - 3 AT THE REQUEST OF THE PATIENTS. ONE HEMIARTHROPLASTY WAS PERFORMED ON 1 PATIENT BECAUSE OF A SECONDARY DISPLACEMENT. FIVE REVERSE SHOULDER ARTHROPLASTIES WERE FITTED: ONE DUE TO PSEUDARTHROSIS AND THE 4 OTHERS DUE TO A SECONDARY DISPLACEMENT. AN OSTEOCHONDRAL FRAGMENT WAS ALSO REMOVED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - SCREWS: PHILOS (QTY 9): -(N=9) SCREW PERFORATION; IMPLANT REMOVAL PERFORMED IN ONE ONHH-RELATED SCREW PERFORATION. A SCREW WAS REPLACED ON 1 PATIENT TO REPAIR A PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304870 UNK - SCREWS: PHILOS SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1