BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4617522 · Received March 19, 2015

    Report

    Report Number
    2520274-2015-11797
    Event Type
    Injury
    Date Received
    March 19, 2015
    Date of Event
    October 3, 2014
    Report Date
    February 25, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ATTINGER, M.C., ET.AL. (2014). "COMPLETE RUPTURE OF THE POPLITEAL ARTERY COMPLICATING HIGH TIBIAL OSTEOTOMY." JOURNAL OF ORTHOPAEDICS II (2014), 192-196. THIS REPORT IS FOR THE UNKNOWN TOMOFIX LOCKING PLATE, UNKNOWN QUANTITY, UNKNOWN LOT. (B)(4) SURGERY WAS PERFORMED. THE 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 JOURNAL ARTICLE, ATTINGER, M.C., ET.AL. (2014). "COMPLETE RUPTURE OF THE POPLITEAL ARTERY COMPLICATING HIGH TIBIAL OSTEOTOMY." JOURNAL OF ORTHOPAEDICS II (2014), 192-196. TWO CASES WERE PRESENTED AS A RESULT OF HIGH TIBIAL OSTEOTOMIES PERFORMED AT AN INSTITUTION. ONE PATIENT WAS TREATED WITH A LOCKING PLATE (TOMOFIX, SYNTHES) AND THE OTHER AN EXTERNAL FIXATOR (MONOTUBE TRIAX, STRYKER). BOTH CASES WERE COMPLICATED WITH THE IMMEDIATE POSTOPERATIVE OCCURRENCE OF AN ISCHAEMIC SYNDROME OF THE LOWER LEG. URGENT DIAGNOSTICS REVEALED A COMPLETE RUPTURE OF THE POPLITEAL ARTERY THAT REQUIRED RE-OPERATION AND A VASCULAR REPAIR. A (B)(6) MALE WITH OSTEOARTHRITIS IN THE MEDIAL FEMOROTIBIAL COMPARTMENT, A CORRECTIVE HIGH TIBIAL OSTEOTOMY WAS PERFORMED. THE OPENING WEDGE WAS FIXED WITH A LOCKING PLATE (TOMOFIX, SYNTHES). PATIENT DEVELOPED SEVERE, UNCONTROLLABLE PAIN AND SWELLING POSTOPERATIVELY, WHICH REQUIRED URGENT VASCULAR SURGERY. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN TOMOFIX LOCKING PLATE AND REFERS TO SEVERE PAIN AND SWELLING POSTOPERATIVELY AND SURGERY. NO REPORTED PRODUCT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188309 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention