BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI COLLAR

    MDR report key: 5144276 · Received October 12, 2015

    Report

    Report Number
    2520274-2015-16578
    Event Type
    Injury
    Date Received
    October 12, 2015
    Report Date
    September 29, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    PMA / PMN Number
    PK082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. EVENT DATE: UNKNOWN. ADDITIONAL CODES- MNI, MNH, KWP, KWO. DEVICE ORIGINALLY IMPLANTED ON AN UNKNOWN DATE IN (B)(6) 2008. MFR DATE: UNKNOWN. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4).DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.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

    IT WAS REPORTED THAT A PATIENT HAD A POSTERIOR FUSION PROCEDURE DONE WITH THE UNIVERSAL SPINE SYSTEM (USS) AT LEVELS L3-L5 ON AN UNKNOWN DATE IN (B)(6) 2008. THE PATIENT HAD A HARDWARE REMOVAL AND WAS REVISED ON (B)(6) 2015, DUE TO ADJACENT LEVEL DISC DISEASE AT LEVEL L2. ALL HARDWARE EXCEPT FOR TWO SCREWS WERE REMOVED TO EXTEND THE CONSTRUCT TO LEVEL L2. THE PATIENT'S HARDWARE REMOVAL CONSISTED OF 4 OF 6 SCREWS, 6 COLLARS, 6 NUTS AND 4 RODS ALSO 2 ADDITIONAL SCREWS WERE PLACED AT LEVEL L2. ALL REMOVED HARDWARE WAS REPLACED WITH NEW IMPLANTS. THERE WERE NO REPORTED FRAGMENTS OR DELAYS, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS IS REPORT 5 OF 20 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674754 6.0MM TI COLLAR ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention