BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSITION 6.5MM POLYAXIAL SCREW, 45MM, ASSEMBLY

    MDR report key: 2038539 · Received March 24, 2011

    Report

    Report Number
    3004142400-2011-00005
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    NQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE PRODUCT WAS NOT RETURNED FOR EVAL; HOWEVER, A REVIEW WAS CONDUCTED OF ALL APPLICABLE MATERIAL RECORDS, MFG RECORDS, STORAGE RECORDS, AND DISTRIBUTION RECORDS. ALL RECORDS REVEALED ALL PRODUCT LOTS WERE MANUFACTURED WITHIN SPECIFICATIONS, MAINTAINED AND DISTRIBUTED IN ACCORDANCE WITH ALL FEDERAL, STATE AND OPERATING PROCEDURES. BASED ON RECORD REVIEW OF ALL AVAILABLE INFO, IT IS DETERMINED THE TRANSITION 6.5MM HA POLYAXIAL SCREW, 45MM, ASSEMBLY - STERILE DESIGN CONFORMS TO ALL APPLICABLE STANDARDS AND THERE WAS NO DEVIATION IN THE MANUFACTURING PROCESS. THERE IS NO INDICATION THAT THE ISSUE WAS A RESULT OF PRODUCT DEFECT OR MALFUNCTION. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    GLOBUS MEDICAL, INC. RECEIVED NOTIFICATION VIA TELEPHONE COMMUNICATION ON (B)(6) 2011 BY A PRODUCT ENGINEER THAT TWO (2) SCREWS BROKE IN A PT AFTER IMPLANTATION. ON (B)(6) 2009 A DISABLED, FEMALE, PT, (B)(6) YRS OLD, UNDERWENT POSTERIOR LUMBAR LAMINECTOMIES AT L4, L5 AND S1, WITH BILATERAL POSTEROLATERAL FUSION AT L4-5 AND L5-S1, AND TRANSITION SEGMENTAL INSTRUMENTATION AT L4-S1 WITH "NUBONE" GRAFT. PT FELL DOWN THE STAIRS IN OCTOBER 2010 BEFORE EXPERIENCING LOW BACK PAIN WITH RADICULOPATHY. POST-OPERATIVE X-RAYS FROM (B)(6)2010, SHOWS TWO (2) L4 POLYAXIAL SCREWS (06.5MM X 45MM LONG) BROKEN. PT UNDERWENT REVISION SURGERY ON (B)(6) 2011 WHEN THE TRANSITION INSTRUMENTATION WAS SEGMENTALLY REMOVED FROM L4-S1, WHICH INCLUDED THE TWO (2) BROKEN SCREWS. SUBSEQUENTLY USED WERE REVERE SEGMENTAL SPINAL INSTRUMENTATION AT L4-S1 WITH AUTOGRAFT AND ALLOGRAFT FROM ORTHOVITA, AND A GLOBUS MEDICAL, INC. PEEK SPACER AT L4-5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSITION 6.5MM POLYAXIAL SCREW, 45MM, ASSEMBLY TRANSITION 6.5MM POLYAXIAL SCREW NQP GLOBUS MEDICAL, INC. 152.465S GBK271CC

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention TRANSITION SEGMENTAL INSTRUMENTATION| "NUBONE" GRAFT