BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.5MM POLYAXIAL SCREW-OPEN 6.5 X 45

    MDR report key: 1022593 · Received April 1, 2008

    Report

    Report Number
    1649384-2008-00185
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    March 7, 2008
    Report Date
    April 1, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTS HAVE BEEN MADE FOR THE RETURN OF THE PRODUCT. REQUEST HAS BEEN MADE TO OBTAIN THE PRODUCT. EVALUATION IS PENDING UPON THE RETURN OF THE PRODUCT.

    Description of Event or Problem · 1

    IN 2008, THE SALES REPRESENTATIVE REPORTED THAT DURING SURGERY THE CLOSURE TOP SHEARED OFF. NO HARM TO PATIENT, SURGERY EXTENDED 15 MINUTES. ADDITIONAL INFORMATION RECEIVED ON THE FOLLOWING MONTH, THE SALES REPRESENTATIVE REPORTED THAT DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) THE SURGEON WAS IMPLANTING A CLOSURE TOP. THE CLOSURE TOP SHEARED THE THREADS ON BOTH THE TULIP HEAD AND THE CLOSURE TOP. THE SURGEON ATTEMPTED TO IMPLANT ANOTHER CLOSURE TOP WHEN THE THREADS FOR THE SECOND CLOSURE TOP SHEARED OFF. THE SURGEON INTERVENED AND EXPLANTED THE CLOSURE TOP AND THE SCREW AND IMPLANTED ANOTHER. THE CASE WAS COMPLETED AS EXPECTED. THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.5MM POLYAXIAL SCREW-OPEN 6.5 X 45 INCOMPASS HWC ABBOTT SPINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention