BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 6068879 · Received November 1, 2016

    Report

    Report Number
    2520274-2016-15132
    Event Type
    Injury
    Date Received
    November 1, 2016
    Report Date
    October 14, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: GRUTZNER, P. A. ET AL (2005). COMPUTER-ASSISTED LISS PLATE OSTEOSYNTHESIS OF PROXIMAL TIBIA FRACTURES: FEASIBILITY STUDY AND FIRST CLINICAL RESULTS. COMPUTER AIDED SURGERY, 10, 141-149. THIS REPORT IS FOR AN UNKNOWN UNREAMED TIBIA NAIL / UNKNOWN QUANTITY / UNKNOWN LOT. (B)(4). 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 LITERATURE ARTICLE, GRUTZNER, P. A. ET AL (2005). COMPUTER-ASSISTED LISS PLATE OSTEOSYNTHESIS OF PROXIMAL TIBIA FRACTURES: FEASIBILITY STUDY AND FIRST CLINICAL RESULTS. COMPUTER AIDED SURGERY, 10, 141-149. THE AUTHORS PRESENTED A CONSECUTIVE CASE STUDY REGARDING REALITY-ENHANCED VIRTUAL FLUOROSCOPY WITH RADIATION-FREE UPDATES OF IN SITU SURGICAL FLUOROSCOPIC IMAGES TO CONTROL LONG-BONE FRACTURE REDUCTION. THE STUDY CONSISTED OF THREE MALE PATIENTS, (38 TO 61 YEARS OF AGE), WITH FOUR FRACTURES OF THE PROXIMAL TIBIA WHO PRESENTED BETWEEN JUNE AND AUGUST 2001. THE PATIENTS WERE PRIMARILY FIXED WITH AN EXTERNAL FIXATOR OR SYNTHES UNREAMED TIBIA NAILING (UTN) AND SECONDARILY STABILIZED WITH SYNTHES LESS INVASIVE STABILIZATION SYSTEM (LISS). ALL PATIENTS WERE IN FOLLOW-UP FOR 18 MONTHS. RESULTS INCLUDED A (B)(6) MALE WITH A PROXIMAL TIBIAL FRACTURE, ASSOCIATION FOR THE STUDY OF INTERNAL FIXATION (AO) C1 REMAINING INSTABILITY AND VARUS DEFORMITY AFTER TREATMENT WITH UTN FOUR MONTHS BEFORE. THE PATIENT UNDERWENT REMOVAL OF UTN AND TREATMENT WITH 13 HOLE LISS. AFTER TREATMENT WITH THE LISS PLATE, THERE WERE NO COMPLICATIONS AND THE PATIENT EXPERIENCED UNEVENTFUL HEALING. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN UNREAMED TIBIA NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722126 NAIL, FIXATION, BONE JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention