BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY SPINAL FIXATION SYSTEM

    MDR report key: 5808022 · Received July 20, 2016

    Report

    Report Number
    0002184052-2016-00131
    Event Type
    Injury
    Date Received
    July 20, 2016
    Report Date
    February 10, 2017
    Manufacturer
    ZIMMER SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK150896
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. (B)(4). UPON RECEIPT OF THE PRODUCT THE PART AND LOT NUMBER OF THE ROD WAS IDENTIFIED, REFERENCE 0002184052-2016-00160.

    Additional Manufacturer Narrative · 1

    CORRECTIONS IDENTIFIED ON AUG. 10, 2016. BRAND NAME CORRECTED FROM TORQUE SET SCREW TO VITALITY SPINAL FIXATION SYSTEM; 510K NUMBER CORRECTED FROM EXEMPT TO K150896.

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Additional Manufacturer Narrative · 1

    THE RETURNED CLOSURE TOPS WERE EXAMINED. THE WITNESS MARKS ON THE BOTTOMS OF THE CLOSURE TOPS, WHICH SIT AGAINST THE ROD TO RETAIN THEM IN PLACE, ARE CONSISTENT WITH INCORRECT ASSEMBLY DURING IMPLANTATION. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONAL INFORMATION IN DEVICE EVALUATED BY MFR?, DEVICE MANUFACTURE DATE, AND EVALUATION CODES.

    Description of Event or Problem · 1

    THE SALES ASSOCIATE REPORTED A PATIENT HAD A REVISION PROCEDURE DUE TO THE TOP TWO SET SCREWS HAD COME OFF THE SCREWS AT L2. THREE SET SCREWS AND A ROD WERE REMOVED AND REPLACED. THE PART NUMBER FOR THE ROD IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462949 VITALITY SPINAL FIXATION SYSTEM SET SCREW NKB ZIMMER SPINE N/A P141351

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R