BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOVEREIGN SPINAL SYSTEM

    MDR report key: 1934724 · Received December 21, 2010

    Report

    Report Number
    1030489-2010-01620
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 25, 2010
    Report Date
    November 25, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MAX
    PMA / PMN Number
    K091813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVER PLATE DOES NOT PRESENT DAMAGE. ONE SMALL BROKEN PIECE WAS NOT RETURNED FOR ANALYSIS. THE CAGE BROKE AT THE LEVEL OF THE HOLDING GROOVES WHICH CORRESPOND TO ONE OF THE SMALLEST TRANSVERSE SECTIONS OF THE CAGE. THE FRACTURE APPEARANCE IS TYPICAL OF OVERLOAD APPLIED TO THE CAGE DURING IMPACTION. THE ANTERIOR SURFACE OF THE CAGE PRESENTS SCRATCHES WHICH CORRESPOND TO THE SUPERIOR OR INFERIOR EDGE OF THE IMPLANT INSERTER FOOTPRINT. IN ADDITION, THE HOLDING SLOT PRESENTS A CRACK OPPOSITE TO THE CONTACT OF THE ANTERIOR SURFACE WITH THE IMPLANT INSERTER REFLECTING A LOAD APPLIED BY THE IMPLANT INSERTED ARM TO THE SLOT. THIS IS ASSUMED TO BE THE START OF THE CAGE BREAKAGE. THOSE TWO CONTACTS INDICATE THAT BENDING MOMENT WAS APPLIED TO THE IMPLANT INSERTER DURING IMPACTION (I.E. THE IMPLANT INSERTER IS ANGLED TO THE CAGE). THE POSTERIOR BROKEN PART PRESENTS LATERALLY A SCRATCH CLOSED TO THE HOLDING GROOVE WHICH COMES FROM THE EXPLANTATION AFTER THE BREAKAGE OF THE CAGE DURING ITS IMPACTION. NO DEFECTS HAVE BEEN FOUND ON THE RE TURNED IMPLANT WHICH CAN BE RESPONSIBLE OF THE BREAKAGE. THE BREAKAGE IS TYPICAL OF OVERLOAD APPLIED DURING IMPACTION. THE LOCALIZATION OF THE BREAKAGE AS WELL AS THE WAY THE MATERIAL HAS DEFORMED SUGGESTS THAT THE BREAKAGE OCCURRED WHILE THE CAGE WAS HALF INSERTED IN THE INTERVERTEBRAL DISC. THE OVERLOADING MIGHT BE DUE TO A BENDING MOMENT APPLIED BECAUSE OF A DIRECTION OF INSERTION ANGLED VERSUS THE DIRECTION OF THE INTERVERTEBRAL DISC. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SPINAL SURGERY, DURING INSERTION OF THE INTERBODY DEVICE, THE DEVICE BROKE TRANSVERSELY BETWEEN THE TIPS OF THE INSERTER. BOTH PARTS WERE REMOVED, AND A NEW DEVICE WAS IMPLANTED IN THE PATIENT WITHOUT ANY FURTHER DIFFICULTIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOVEREIGN SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDTRONIC SOFAMOR DANEK SC40

    Patients

    Seq Age Sex Outcome Treatment
    1 00032 DA