BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 2594844 · Received May 31, 2012

    Report

    Report Number
    1030489-2012-00754
    Event Type
    Malfunction
    Date Received
    May 31, 2012
    Date of Event
    May 2, 2012
    Report Date
    May 2, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL INTERPRETATION: OFFERED ARE TWO LATERAL VIEWS OF A MULTIPLE LEVEL CERVICAL ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) FROM C3 TO C7. THERE IS A CONGENITAL FUSION AT C2 - C3. INTERBODY SPACERS ARE PRESENT AND IN GOOD POSITION. THE SECOND FILM SHOWS THAT ONE OF THE C3 BONE SCREWS HAS BACKED OUT PARTIALLY, SUGGESTING FAILURE OF THE LOCKING MECHANISM. OVERALL ALIGNMENT REMAINS GOOD.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS IS NOT POSSIBLE ON (B)(4) 2012 WITHOUT ADDITIONAL DEVICE INFORMATION. A REVIEW OF THE COMPLAINT HISTORY FOR ATLANTIS TRANSLATIONAL PRODUCT FAMILY, CONDUCTED (B)(4) 2012 DID NOT IDENTIFY ANY APPLICABLE COMPLAINT TRENDS FOR THIS FAILURE MODE. A REVIEW OF THE COMPLAINT HISTORY FOR PARTS, 6190077, 3120514 AND 3120315, CONDUCTED ON (B)(4) 2012, DID NOT IDENTIFY ANY APPLICABLE COMPLAINT TRENDS WITH FURTHER EVALUATION OF THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) FROM C3 TO C7 FOR MYELOPATHY USING A DEVICE. DURING ROUTINE FOLLOW UP VISIT (TWO TO THREE WEEKS POST-OP), X-RAYS SHOWED TWO SCREWS BACKED OUT PAST THE LOCKING MECHANISM. THE SCREWS WERE LOCATED AT THE DISTAL ENDS OF THE PLATE. IMAGING FILMS WERE PROVIDED. THE DOCTOR WILL MONITOR ANY PATIENT COMPLICATIONS AND ASSESS REVISION OF INSTRUMENTATION AS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS 3120514 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR