BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOAXIAL PEDICLE SCREW DG 40

    MDR report key: 6173315 · Received December 14, 2016

    Report

    Report Number
    3003853072-2016-00156
    Event Type
    Injury
    Date Received
    December 14, 2016
    Date of Event
    October 19, 2016
    Report Date
    January 30, 2018
    Manufacturer
    ZIMMER SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK111301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION IN IMPLANT DATE, DEVICE MANUFACTURE DATE, AND EVALUATION CODES: METHOD CODES. THE DEVICE WAS NOT RETURNED SO AN EVALUATION COULD NOT BE PERFORMED AND NO CONCLUSIONS COULD BE DRAWN. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THE LABELING WAS REVIEWED AND FOUND TO CONTAIN INFORMATION REGARDING POST-OPERATIVE EXPECTATIONS.

    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. THIS IS REPORT SIX OF SIX FOR THIS EVENT. REFERENCE REPORT NUMBERS 3003853072-2016-00151 THRU 3003853072-2016-00156.

    Additional Manufacturer Narrative · 1

    THE RETURNED SCREW WAS EVALUATED. THERE WERE NO FAILURES DETECTED. THE COMPLAINT WAS NOT CONFIRMED FOR THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 15 MONTHS AFTER INSTALLATION, THE PATIENT PRESENTED TO THE SURGEON WITH PAIN. X-RAYS WERE TAKEN AND THE SURGEON SAW SIGNS THAT THE TULIP OF THE PEDICLE SCREW AT LEFT L-3 DETACHED FROM THE SCREW SHANK. IT APPEARED THAT THE PEDICLE SCREW AT RIGHT L-3 WAS ALSO BROKEN, AS WELL AS THE ROD BETWEEN THE L-3 AND L-4 LEVELS. A REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE IMPLANTS. THERE WERE A TOTAL OF TWO RODS AND FOUR PEDICLE SCREWS REMOVED; IT IS NOT YET CLEAR WHICH ROD AND PEDICLE SCREWS ARE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824778 MONOAXIAL PEDICLE SCREW DG 40 INSTINCT JAVA SYSTEM NKB ZIMMER SPINE N/A E51198

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R