BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPENING JACK BACK ARM

    MDR report key: 2822232 · Received May 23, 2012

    Report

    Report Number
    1220246-2012-00093
    Event Type
    Injury
    Date Received
    May 23, 2012
    Date of Event
    April 27, 2012
    Report Date
    April 30, 2012
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS RECEIVED AND AN EVALUATION WAS CONDUCTED. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. COMPLAINT CONFIRMED. THE EVALUATION REVEALED THAT THE TWO RETURNED MATING PARTS, AN (B)(4), OPENING JACK TURN KEY, AND THE (B)(4), JACK BACK ARM, WERE LODGED TOGETHER AND COULD NOT BE TAKEN APART. THIS COMPLAINT IS STILL UNDER INVESTIGATION. AT THE CURRENT TIME THE CAUSE OF THE EVENT CANNOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED FROM THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CASE WAS GOING SMOOTHLY UNTIL THE DOCTOR USED THE OSTEOTOMY JACK TO OPEN HIS CUT. THE JACK STOPPED OPENING OR CLOSING ONCE HE HAD THE CUT OPEN TO ABOUT 5MM. WITH NO OTHER WAY TO OPEN OSTEOTOMY, HE DECIDED HE COULD NOT USE THE IBALANCE IMPLANT. DOCTOR TRIED TO OPEN OSTEOTOMY WITH SMOOTH LAMINA SPREADERS, BUT THE TIBIA WAS TOO UNSTABLE AND WAS ROTATING. HE DECIDED TO PLATE WITH SYNTHES LOCKING PROXIMAL TIBIA PLATEAU AND COME BACK IN THREE MONTHS TO FINISH HTO WITH PUDDU/LOCKING PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPENING JACK BACK ARM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. 221126

    Patients

    Seq Age Sex Outcome Treatment
    1 Other OPENING JACK TURN KEY: (B)(4)