BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI PANGEA(TM) LOCKING CAP

    MDR report key: 4241239 · Received November 10, 2014

    Report

    Report Number
    2520274-2014-14597
    Event Type
    Injury
    Date Received
    November 10, 2014
    Report Date
    October 16, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    NKB
    PMA / PMN Number
    PK082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT DATE APPROXIMATELY 3 YEARS PRIOR TO REVISION DATE, ACTUAL DATE UNKNOWN. (B)(6). 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. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED A PATIENT APPROXIMATELY 3 YEARS STATUS POST LUMBAR FUSION WITH PANGEA SYSTEM WAS RETURNED TO THE OPERATING ROOM FOR REVISION SURGERY ON (B)(6) 2014 DUE TO NON-FUSION BETWEEN L4 AND L5. THE PANGEA IMPLANTS WERE REMOVED, AND THE SURGEON NOTICED THAT THE PANGEA LOCKING CAP AT L5 (RIGHT) WAS LOOSE. SINCE THE LOCKING CAP WAS LOOSE, ADDITIONAL LOAD WAS PLACED ON THE SCREWS TO THE LEFT, AND THE SCREW AT L5 (LEFT) BECAME LOOSE. THE REVISION SURGERY WAS COMPLETED WITH NO REPORTED TIME DELAY. PATIENT STATUS/OUTCOME FOLLOWING THE PROCEDURE WAS NOT PROVIDED. THIS IS REPORT 2 OF 10 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723847 TI PANGEA(TM) LOCKING CAP ORTHOSIS, SPINAL PEDICLE, FIXATION FOR DDD NKB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention