BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPDLNK 5.5 TRANS CNTR MED 43-51MM

    MDR report key: 1150237 · Received September 3, 2008

    Report

    Report Number
    1649384-2008-00467
    Event Type
    Injury
    Date Received
    September 3, 2008
    Date of Event
    August 6, 2008
    Report Date
    September 3, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW INDICATES THE PART MET SPECS. VISUAL EXAMINATION OF THE RETURNED PRODUCT FOUND THE CAM STUCK AND THE CONNECTING BAR CRACKED. THE DAMAGE SUGGESTS THE SURGEON INSERTED THE SPEEDLINK IN A NOT FULLY UNLOCKED POSITION AND TRIED TO FORCE THE SPEEDLINK INTO THE DESIRED POSITION WITHOUT PROPERLY PLACING IT FIRST PER THE SURGICAL TECHNIQUE. THE EVENT IS DUE TO USE ERROR. NOTE: A REPORT OR OTHER INFO SUBMITTED BY A REPORTING ENTITY UNDER THIS PART, AND ANY RELEASE BY FDA OF THAT REPORT OF INFO, DOES NOT NECESSARILY REFLECT A CONCLUSION BY THE PARTY SUBMITTING THE REPORT TO FDA THAT THE REPORT OF INFO CONSTITUTES AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, OR ITS EMPLOYEES OR AGENTS CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. THE REPORTING ENTITY NEED NOT ADMIT AND MAY DENY (AND MAY EXPRESSLY RESERVE THE RIGHT TO DENY) THAT THE DEVICE, THE PARTY SUBMITTING THE REPORT OR EMPLOYEES THEREOF CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT IN 2008, THE PT WAS UNDERGOING INITIAL FUSION SURGERY. WHEN THE SURGEON WAS BENDING THE ROD, THE CONNECTOR ARM BROKE. THE SURGEON REMOVED THE DEVICE WHICH DID NOT GO ANY FURTHER INTO THE SURGICAL WOUND. ANOTHER SPEEDLINK WAS USED AND THE SURGERY WAS COMPLETED AS INDICATED. VISUAL EXAMINATION OF THE RETURNED PART INDICATES THE ARM IS CRACKED BUT NOT BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPDLNK 5.5 TRANS CNTR MED 43-51MM SPEEDLINK KWP ABBOTT SPINE 44KN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention