BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS

    MDR report key: 22175451 · Received June 10, 2025

    Report

    Report Number
    8030965-2025-05789
    Event Type
    Injury
    Date Received
    June 10, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: H3, H6: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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 ARTICLE HAS BEEN REVIEWED: LIU C, LUO W, MA J, YE S, ZHAO B, BAI H, XING F, JIANG X, MA X. CHANGES IN PATELLAR HEIGHT AND TIBIAL POSTERIOR SLOPE AFTER BIPLANAR HIGH TIBIAL OSTEOTOMY WITH COMPUTER-DESIGNED PERSONALIZED SURGICAL GUIDES: A RETROSPECTIVE STUDY. ORTHOP SURG. 2024 MAY;16(5):1143-1152. DOI: 10.1111/OS.14049. EPUB 2024 APR 1. PMID: 38561920; PMCID: PMC11062865. OBJECTIVE/METHODS/STUDY DATA: THE OBJECTIVES OF THIS RETROSPECTIVE COHORT STUDY ARE: (I) TO INTRODUCE THE SURGICAL TECHNIQUE OF PERSONALIZED SURGICAL GUIDE PLATE (PSGP)-ASSISTED MOWHTO; AND (II) TO INVESTIGATE THE IMPACT OF THE DEGREE OF CORRECTION ON PATELLAR HEIGHT (PH) AND POSTERIOR TIBIAL SLOPE ANGLE (PTSA) IN PERSONALIZED SURGICAL GUIDE PLATE (PSGP)-ASSISTED MEDIAL OPENING-WEDGE HIGH TIBIAL OSTEOTOMY (MOWHTO). BETWEEN MARCH TO SEPTEMBER 2022, A TOTAL OF 107 PATIENTS WERE INCLUDED IN OUR STUDY. THE COHORT INCLUDED 38 MALES (35.5%) AND 69 FEMALES (64.5%), WITH AN AVERAGE AGE OF 61.9 + 7.19, RANGING FROM 36 TO 76 YEARS, WERE TREATED USING TOMOFIX LOCKING PLATE. ALL PATIENTS WERE FOLLOWED UP IN THE OUTPATIENT CLINIC AT 1 MONTH, 3 MONTHS, 6 MONTHS, AND 1 YEAR POSTOPERATIVELY. LOT, MODEL AND CATALOG NUMBERS ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SYNTHES TOMOFIX. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS (QTY 3): 1 PATIENT WAS FOUND TO HAVE A SUPERFICIAL INFECTION POSTOPERATIVELY, WHICH WAS CURED WITH NON-SURGICAL TREATMENT. 2 PATIENTS UNDERWENT SURGICAL TREATMENT FOR DEEP VEIN THROMBOSIS IN THE LOWER LIMBS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1266115 UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention