BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS

    MDR report key: 12674497 · Received October 21, 2021

    Report

    Report Number
    8030965-2021-08866
    Event Type
    Injury
    Date Received
    October 21, 2021
    Date of Event
    June 26, 2012
    Report Date
    September 23, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    MNI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNK - CONSTRUCTS: TOMOFIX PLATE/ SCREWS/ UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. 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 · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: PEERBOOMS J., ETA L (2012) NO POSITIVE BONE HEALING AFTER USING PLATELET-RICH PLASMA IN A SKELETAL DEFECT. AN OBSERVATIONAL PROSPECTIVE COHORT STUDY, INTERNATIONAL ORTHOPAEDICS (SICOT) VOLUME 36, PAGES 2113¿2119 (NETHERLANDS). THIS OBSERVATIONAL PROSPECTIVE COHORT STUDY AIMS TO COMPARE TWO GROUPS TO INVESTIGATE WHETHER THE USE OF PLATELET-RICH PLASMA (PRP) MIXED WITH BONE CHIPS IMPROVES BONE HEALING IN PATIENTS WITH A SKELETAL DEFECT. BETWEEN OCTOBER 2005 AND FEBRUARY 2009, 41 PATIENTS WITH HIGH MEDIAL TIBIAL OSTEOTOMIES UNDERWENT SURGERY. TWENTY PATIENTS (WITH 7 MALES) WERE TREATED WITH PRP AND 21 (WITH 8 MALES) WITHOUT PRP. THE COHORT CONSISTS OF 16 MALES AND 25 FEMALES WITH AN AVERAGE AGE OF 51.0 YEARS (SD07.3). FROM THE PRP GROUP, ONE PATIENT WAS EXCLUDED DUE TO INSUFFICIENT REGISTRATION OF DATA. FROM THE CONTROL GROUP, FIVE PATIENTS WERE EXCLUDED FOR SIMILAR REASONS. THE LEFT-RIGHT RATIO WAS 21:20. NINETEEN PATIENTS RECEIVED PRP (PRP GROUP), WHILE THE OTHER PATIENTS DID NOT RECEIVE PRP (CONTROL GROUP). INTERNAL FIXATION WAS PERFORMED USING THE TOMOFIX PLATE (SYNTHESGMBH, SOLOTHURN, SWITZERLAND). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: AT ONE WEEK POSTOPERATIVELY, THE BONE DENSITY UNDER THE WEDGE WAS SIGNIFICANTLY LOWER IN THE PRP GROUP 50.8 (SD 37.8) THAN THE CONTROL GROUP 119.0 (SD 94.6; P00.02). WHERE HIGH BONE DENSITY REFLECTS GOOD BONE HEALING. THIS REPORT IS FOR AN UNKNOWN SYNTHES TOMOFIX PLATE. THIS REPORT IS FOR ONE (1) UNK - CONSTRUCTS: TOMOFIX PLATE/ SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1573082 UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS ORTHOSIS, PEDICLE SPINAL FIXATION MNI SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention