BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4597718 · Received March 13, 2015

    Report

    Report Number
    2520274-2015-11454
    Event Type
    Injury
    Date Received
    March 13, 2015
    Report Date
    February 25, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT FOR DIAGNOSIS. KOLB, W. ET AL (2009). OPENING-WEDGE HIGH TIBIAL OSTEOTOMY WITH A LOCKED LOW-PROFILE PLATE. J BONE JOINT SURG AM., 91, 2581-2588. THIS REPORT IS FOR AN UNKNOWN TOMOFIX/UNKNOWN QUANTITY/UNKNOWN LOT. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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 SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE, KOLB, W. ET AL (2009). OPENING-WEDGE HIGH TIBIAL OSTEOTOMY WITH A LOCKED LOW-PROFILE PLATE. J BONE JOINT SURG AM., 91, 2581-2588. THIS IS A PROSPECTIVE STUDY FROM SEPTEMBER 2002 TO NOVEMBER 2005; FIFTY-ONE CONSECUTIVE MEDIAL OPENING-WEDGE HIGH TIBIAL OSTEOTOMIES WERE PERFORMED. THE MEAN AGE OF THE PATIENTS AT THE TIME OF THE INDEX OPERATION WAS FORTY-NINE YEARS. THE STUDY WAS TO EVALUATE THE CORRECTION OF OSSEOUS MALALIGNMENT AND TO ANALYZE THE SHORT-TERM RESULTS OF MEDIAL OPENING-WEDGE HIGH TIBIAL OSTEOTOMY WITH LOCKED PLATE FIXATION. INTERNAL FIXATORS WITH LOCKED SCREWS ALLOW THE HEALING OF THE OSTEOTOMY WITHOUT COMPRESSION BETWEEN THE PLATE AND BONE, AND, IN MOST PATIENTS, BONE GRAFTS CAN BE AVOIDED. TOMOFIX (SYNTHES, (B)(4)) IS AN ANATOMICALLY PRECONTOURED INTERNAL FIXATOR FOR THE PROXIMAL-MEDIAL ASPECT OF THE TIBIA THAT IS INSERTED INTO A SUBCUTANEOUS TUNNEL WITH MINIMAL BONE EXPOSURE. FIFTY OF THE FIFTY-ONE OSTEOTOMIES HEALED AFTER AN AVERAGE PERIOD OF 12.9 WEEKS WITHOUT BONE GRAFTS. A NONUNION DEVELOPED IN A (B)(6) PATIENT WHO WAS A CIGARETTE SMOKER. AFTER THIRTEEN MONTHS, THE PATIENT HAD A REVISION OSTEOSYNTHESIS WITH A TOMOFIX DEVICE AND AN AUTOGENOUS ILIAC CREST GRAFT THAT HEALED WITHOUT FURTHER COMPLICATIONS. FORTY-NINE PATIENTS WERE FOLLOWED FOR A MEAN OF FIFTY-TWO MONTHS. THE RATING WAS EXCELLENT IN TWENTY-EIGHT PATIENTS, GOOD IN TWELVE, FAIR IN FOUR AND POOR IN FIVE. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN TOMOFIX AND REFERS TO THE SERIOUS INJURY OF THE (B)(4) PATIENT WHO EXPERIENCED NONUNION AND UNDERWENT REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173763 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention