BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYAXIAL PEDICLE SCREW

    MDR report key: 2894159 · Received December 27, 2012

    Report

    Report Number
    3003853072-2012-00027
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    April 19, 2012
    Report Date
    April 23, 2012
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL ANALYSIS OF THE RETURNED DEVICE CONFIRMED THE REPORTED EVENT. MFG RECORDS REVIEWED INDICATED NO DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THIS EVENT WAS OPERATIONAL CONTEXT AS THE DEVICE PERFORMANCE WAS LIMITED BY PROCEDURAL/ANATOMICAL FACTORS. THIS IS THE FINAL REPORT THAT WILL BE SUBMITTED ASSOCIATED WITH THIS INCIDENT AND DEVICE. NO ADD'L ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLOCKER LOOSENED POST-OPERATIVELY. LEVELS TREATED DURING THE INDEX SURGERY WERE L4-L5 FOR INSTABILITY AND DISLOCATION OF THE VERTEBRAL BODY PRESSING ON THE NERVE ROOTS. THREE MONTHS POST-OPERATIVELY, THE PATIENT EXPERIENCED A FALL. FURTHER X-RAYS REVEALED THE ROD HAD SLIPPED OUT OF POSITION IN THE CONSTRUCT. DURING REVISION, IT WAS FOUND THE BLOCKER WAS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYAXIAL PEDICLE SCREW POLYAXIAL PEDICLE SCREW NKB ZIMMER SPINE, INC. 046W0AN26545 H15668E

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention