BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PLATES: TOMOFIX OSTEOTOMY

    MDR report key: 22113034 · Received May 30, 2025

    Report

    Report Number
    8030965-2025-05459
    Event Type
    Injury
    Date Received
    May 30, 2025
    Date of Event
    August 6, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    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 MANUFACTURER NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE.

    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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: ZINDEL C, HODEL S, JUD L, ZIMMERMANN SM, VLACHOPOULOS L, FUCENTESE SF. ACCURACY OF COMBINED HIGH TIBIAL SLOPE CORRECTION OSTEOTOMY USING 3-DIMENSIONAL-PLANNED PATIENT-SPECIFIC INSTRUMENTATION. AM J SPORTS MED. 2024 DEC;52(14):3578-3586. DOI: 10.1177/03635465241295726. EPUB 2024 NOV 24. PMID: 39582220; PMCID: PMC11608524. OBJECTIVE/METHODS/STUDY DATA: THE PURPOSE OF THE STUDY WAS (1) TO EVALUATE THE ACCURACY OF PATIENT-SPECIFIC INSTRUMENTS (PSI)-NAVIGATED HIGH TIBIAL SLOPE CORRECTION OSTEOTOMIES (HTSCO) AND (2) TO ANALYZE THE INFLUENCE OF OPENING WEDGE OSTEOTOMIES (OWO), CLOSING WEDGE OSTEOTOMIES (CWO), AND THE HINGE AXIS ANGLE (HAA) ON THE ACCURACY OF THE POSTERIOR TIBIAL SLOPE (PTS) CORRECTION. BETWEEN JANUARY 2019 AND JULY 2022, A TOTAL OF 18 PATIENTS (16 MALE, 2 FEMALE) WITH A MEAN AGE OF 31.1 ± 10.4 YEARS (RANGE, 17-47) WERE INCLUDED IN THE STUDY. THE PATIENTS WERE TREATED WITH TOMOFIX MEDIAL HIGH TIBIAL PLATE. MEAN FOLLOW-UP WAS 17.5 ± 9.3 MONTHS (RANGE, 5-35). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: TOMOFIX MEDIAL HIGH TIBIAL PLATE AND SCREWS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - PLATES: TOMOFIX OSTEOTOMY (QTY: 13). 13 CASES REPORTED REMOVAL OF PLATE DUE TO IRRITATING HARDWARE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS: MEDIAL HIGH TIBIA (QTY: 2). 1 PATIENT HAD A LOOSE BODY IN THE KNEE JOINT, WHICH WAS ARTHROSCOPICALLY REMOVED 7 MONTHS AFTER THE INITIAL OPERATION. 1 PATIENT HAD WOUND-HEALING DISORDER OCCURRED WITH CONSEQUENT REVISION SURGERY INCLUDING PLATE EXCHANGE AND ANTIBIOTIC TREATMENT FOR 8 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35434 UNK - PLATES: TOMOFIX OSTEOTOMY PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention