BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI SOFT ROD 500MM

    MDR report key: 2802520 · Received October 24, 2012

    Report

    Report Number
    2520274-2012-02485
    Event Type
    Injury
    Date Received
    October 24, 2012
    Report Date
    September 25, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    MNI
    PMA / PMN Number
    K990745
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE WAS IMPLANTED APPROXIMATELY ONE YEAR AGO (2011). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH SCOLIOSIS WAS IMPLANTED WITH A LONG CONSTRUCT ON AN UNKNOWN DATE APPROXIMATELY ONE YEAR AGO. IT WAS REPORTED THAT THE PATIENT WAS DOING FINE POST-OPERATIVELY. THE PATIENT WAS RETURNED TO A HOSPITAL IN GAINESVILLE, FL FOR GALLBLADDER SURGERY ON AN UNKNOWN DATE. AFTER THE GALLBLADDER SURGERY, THE PATIENT IMMEDIATELY COMPLAINED OF BACK PAIN. PATIENT RETURNED TO THE SURGEON ON AN UNKNOWN DATE AND X-RAYS WERE TAKEN OF HER BACK AND X-RAYS REVEALED TWO RODS BROKE POST-OPERATIVELY. THE ROD ON THE RIGHT SIDE WAS BROKEN FROM L1 TO L2. THE ROD ON THE LEFT SIDE WAS BROKEN FROM L3-L4. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2012 FOR REVISION SURGERY. THE SURGEON NOTED INTER-OPERATIVELY THAT THERE WAS A NON-UNION AT LEVELS L1-L2 AND L3-L4; ALL OTHER LEVELS WERE FUSED. SURGEON REMOVED TWO TRANSCONNECTORS AND ONE SCREW. THE BROKEN BI-LATERAL RODS REMAINS IMPLANTED IN THE PATIENT. THE SURGEON CONNECTED THE NEW RODS ONTO THE EXISTING RODS. SURGEON IMPLANTED TWO NEW RODS, FOUR PARALLEL CONNECTORS, THREE SCREW AND TWO ADDITIONAL TRANSCONNECTORS TO STABILIZE THE CONSTRUCT. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.0MM TI SOFT ROD 500MM 6.0MM TI SOFT ROD MNI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention ROD