BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAEDIATRIC LR C/D UNIT EXTENDS TO 6.2 CM

    MDR report key: 3605538 · Received December 10, 2013

    Report

    Report Number
    9680825-2013-00037
    Event Type
    Malfunction
    Date Received
    December 10, 2013
    Date of Event
    September 16, 2013
    Report Date
    December 6, 2013
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JDW
    PMA / PMN Number
    K955848
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS: THE DEVICE INVOLVED IN THIS EVENT HAS NOT YET BEEN REC'D BY ORTHOFIX SRL. UNFORTUNATELY, ALSO THE DEVICE BATCH NUMBER HAVE NOT BEEN MADE AVAILABLE AND THEREFORE, IT WAS NOT POSSIBLE TO PERFORM THE VERIFICATION OF THE HISTORICAL DATA. TECHNICAL EVAL: THE DEVICE INVOLVED IN THIS EVENT HAS NOT YET BEEN REC'D BY ORTHOFIX SRL. THE TECHNICAL EVAL WILL BE PERFORMED AS SOON AS THE DEVICE BECOMES AVAILABLE. MFR EVAL: THE INFO AVAILABLE ON THE CASE WAS SENT TO OUR MEDICAL EVALUATOR. A PRELIMINARY MEDICAL EVAL IS CURRENTLY ONGOING AND WILL BE FINALIZED ONCE THE RESULTS OF THE TECHNICAL EVAL WILL BE AVAILABLE. MFR COMMENTS: ORTHOFIX SRL HAS REQUESTED FURTHER INFO ON THE EVENT SUCH AS COPIES OF THE OPERATIVE REPORT AND COPIES OF THE PRE AND POST-OPERATIVE X-RAYS AND DEVICE AVAILABILITY FOR THE TECHNICAL EVAL. AS SOON AS FURTHER INFO WILL BE AVAILABLE, ORTHOFIX SRL WILL PROVIDE YOU WITH A F/U REPORT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 1

    THE INFO INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: HOSPITAL CLINIC (B)(6). SURGEON NAME:(B)(6). PT DIAGNOSIS: TIBIA'S DEFORMITY. DATE OF SURGERY: (B)(6) 2013. SURGERY DESCRIPTION: THE SURGEON MADE AN OSTEOTOMY AND PUT A PEDIATRIC EXTERNAL FIXATOR. PT INFO: (B)(6) YRS OLD, (B)(6) KG. PLANNED TREATMENT: THREE MONTHS OF LENGTHENING, 1MM PER DAY DISTRACTION UNIT GET BROKEN WHEN THE PT'S FATHER WAS MAKING THE DISTRACTION WITH THE ALLEN KEY. DATE OF DEVICE FAILURE: (B)(6) 2013. DATE OF REPLACEMENT: (B)(6) 2013. DATE OF REPLACEMENT: (B)(6) 2013. NO ADVERSE EFFECTS TO PT, AN ADD'L SURGERY WAS NOT REQUIRED. INFO ON PT CURRENT HEALTH CONDITION: HE WAS NOT AFFECTED BY THE ACCIDENT OF THE BROKEN DISTRACTOR. MFR REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645211 PAEDIATRIC LR C/D UNIT EXTENDS TO 6.2 CM PAEDIATRIC LRS C/D UNIT EXTENDS TO 6.2 C JDW ORTHOFIX SRL 55008 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR NO INFO HAS BEEN MADE AVAILABLE.