BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: TOMOFIX

    MDR report key: 13904635 · Received March 25, 2022

    Report

    Report Number
    8030965-2022-01927
    Event Type
    Injury
    Date Received
    March 25, 2022
    Date of Event
    December 22, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BETWEEN JUNE 2009 AND SEPTEMBER 2015, 85 PATIENTS WHO UNDERWENT OPEN WEDGE HIGH TIBIAL OSTEOTOMY FOR MEDIAL COMPARTMENT KNEE OSTEOARTHRITIS WERE INCLUDED IN THE STUDY. THE PATIENTS WERE DIVIDED INTO 2 GROUPS: NON-GRAFTED AND GRAFTED GROUPS. THE NON-GRAFTED GROUP COMPRISED OF 40 PATIENTS (10 MALES AND 30 FEMALES, MEAN AGE 62.2 YEARS (RANGE 42 TO 74) WHILE THE GRAFTED GROUP COMPRISED OF 45 PATIENTS (15 MALES AND 30 FEMALES, MEAN AGE 65.3 YEARS (RANGE 46 TO 80). EXACT DATE OF EVENT IS UNKNOWN; (B)(6) 2021 IS THE DATE THE LITERATURE ARTICLE WAS PUBLISHED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: R. NAKAMURA, N. KOMATSU, K. FUJITA ET AL. (2021), ANTEROMEDIAL PLATING WITHOUT FILLING THE GAP IN OPEN WEDGE HIGH TIBIAL OSTEOTOMY MAY INCREASE THE RISK OF SCREW BREAKAGE, WHICH CAN BE REDUCED BY MEDIAL PLATING AND BONE-SUBSTITUTE INSERTION, JOURNAL OF ORTHOPAEDIC SCIENCE, PAGES 1-10, HTTPS://DOI.ORG/10.1016/J.JOS.2021.12.017 (JAPAN). THE FIRST OBJECTIVE OF THIS RETROSPECTIVE STUDY WAS TO COMPARE THE RATE OF DELAYED ONSET BONE/IMPLANT-RELATED COMPLICATIONS SUCH AS SCREW BREAKAGE WITH AND WITHOUT CORRECTION LOSS AND TIME-DEPENDENT INCREASE OF THE POSTERIOR TIBIAL SLOPE BETWEEN GRAFTED AND NONGRAFTED GROUPS. THE SECOND OBJECTIVE WAS TO CLARIFY THE EFFECT OF THE PLATE INSTALLATION ANGLE AND THE SCREW INSERTION DEPTH ON THE RATE OF BONE/IMPLANT-RELATED COMPLICATIONS. BETWEEN JUNE 2009 AND SEPTEMBER 2015, 85 PATIENTS WHO UNDERWENT OPEN WEDGE HIGH TIBIAL OSTEOTOMY FOR MEDIAL COMPARTMENT KNEE OSTEOARTHRITIS WERE INCLUDED IN THE STUDY. THE PATIENTS WERE DIVIDED INTO 2 GROUPS: NON-GRAFTED AND GRAFTED GROUPS. THE NON-GRAFTED GROUP COMPRISED OF 40 PATIENTS (10 MALES AND 30 FEMALES, MEAN AGE 62.2 YEARS (RANGE 42 TO 74) WHILE THE GRAFTED GROUP COMPRISED OF 45 PATIENTS (15 MALES AND 30 FEMALES, MEAN AGE 65.3 YEARS (RANGE 46 TO 80). THE OPEN WEDGE HIGH TIBIAL OSTEOTOMY FIXATION WAS PERFORMED USING AN UNKNOWN SYNTHES TOMOFIX OSTEOTOMY SYSTEM (SMALL SIZE). IN THE NON-GRAFTED GROUP, A BONE SPREADER WAS INSERTED INTO THE POSTERIOR GAP AFTER OSTEOTOMY. IN THE GRAFTED GROUP, A COMPETITOR¿S BONE-SUBSTITUTE BLOCK MADE OF B-TRICALCIUM PHOSPHATE WAS USED. TIME TO PLATE REMOVAL WAS BETWEEN 1.5 AND 2.5 YEARS. COMPLICATIONS WERE REPORTED AS FOLLOWS: CASE 9, PATIENT HAD BREAKAGE OF THE MIDDLE, POSTERIOR, AND LOWER MIDDLE PROXIMAL SCREWS. PATIENT ALSO HAD A CORRECTION LOSS AND WAS CONVERTED TO TOTAL KNEE ARTHROPLASTY. THIS REPORT IS FOR UNKNOWN TOMOFIX SCREWS. THIS IS REPORT 9 OF 18 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010300 UNK - SCREWS: TOMOFIX SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention