BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 4274514 · Received November 24, 2014

    Report

    Report Number
    1030489-2014-04559
    Event Type
    Injury
    Date Received
    November 24, 2014
    Date of Event
    December 23, 2003
    Report Date
    August 15, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    K970806
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). UNK DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: 876-313 / LOT: UNKNOWN (X1) PART: 876-123 / LOT: UNKNOWN (X1) PART: 876-013 / LOT: UNKNOWN (X2) PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY MEDTRONIC DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLINICAL STUDY CONTROL PATIENT UNDERWENT AN ACDF PROCEDURE AT LEVEL C6-C7. THE FOLLOWING POST-OPERATIVE EVENT WAS REPORTED: POST OP VISIT DATE-2004/01/16 AE ONSET DATE: (B)(6) 2003; AE DESCRIPTION: C/O CONTINUED PAIN RT. ARM OTHER TREATMENT: MRI PLANNED POST OP VISIT DATE-2004/03/30 MEDICATION: YES; ADDITIONAL TREATMENT: 1. REFERRED TO OCCUPATIONAL MEDICINE SPECIALIST 2. HYDROCODONE CHANGED TO DARVOCET ADDITIONAL COMMENTS: F/U APPT. SCHEDULED WITH DR. LIM PT C/O SUBOCCIPITAL HEADACHES AND INTRASCAPULAR PAIN POST OP VISIT DATE-2004/06/08 REFERRED TO SPECIALIST: YES; OTHER TREATMENT: CERVICAL MYELOGRAM ADDITIONAL TREATMENT: CERVICAL MYELOGRAM ORDERED. ALSO, PT. SAW OCCUPATIONAL MEDICINE PHYSICIAN. ADDITIONAL COMMENTS: F/U WITH DR. LIM FOLLOWING MYELOGRAM. PT. FEELS RIGHT ARM SYMPTOMS ARE WORSENING AS COMPARED TO PRE-OP POST OP VISIT DATE-2005/02/15 ADDITIONAL TREATMENT: FOLLOW UP APPT. 3 MO. AND POSSIBLE CERVICAL MRI. ADDITIONAL COMMENTS: PT. CONTINUES TO C/O RIGHT-SIDED NECK, SCAPULAR AND ARM SYMPTOMS POST OP VISIT DATE-2005/11/29 ADDITIONAL COMMENTS: PT DENIES HEADACHES BUT STOP C/O INTRASCAPULAR PAIN POST OP VISIT DATE-2008/02/28 TREATMENT: NO; DESCRIPTION: PT. STATES INTRASCAPULAR PAIN IS THE SAME. RESULTS OF MRI 5/17/06 C6-C7 MILD SPINAL CANAL NARROWING C5-C6/C4-C5 MODERATE CANAL NARROWING SMALL POSTERIOR BULGE OR PROTRUSION OSTEOPHYTE COMPLEXES C3-4 MILD CANAL NARROWING SMALL POSTERIOR BULGE OR PROTRUSION / OSTEOPHYTE COMPLEX. RESULTS OF MRI 05/17/05 C6-7 MILD CONGENITAL SPINAL CANAL NARROWING C5-6/C4-5 MODERATE CANAL NARROWING, SMALL POSTERIOR OSTEOPHYTE COMPLEXES. C3-4 MILD CANAL NARROWING SMALL POSTERIOR BULGE OR PROTRUSION/OSTEOPHYTE COMPLEX; ADDITIONAL COMMENTS: PT. REFUSED THE OFFER OF AN EPIDURAL STEROID INJECTION POST OP VISIT DATE-2004/03/30 AE ONSET DATE: 2004/01/16; AE DESCRIPTION: THE HEAD OF THE RIGHT-SIDED C7 VERTEBRAL BODY SCREW IS RETRACTED 6-7 M FROM THE ANTERIOR FUSION PLATE. TREATMENT: NO; POST OP VISIT DATE-2004/06/08 DESCRIPTION: FOLLOW ON X-RAY POST OP VISIT DATE-2005/02/15 ADDITIONAL TREATMENT: POSITION OF FIXATION SCREW HAS COME OUT OF PLATE AND EXTENDS INFERIORLY AND TO THE RIGHT OF THE INFERIOR PLATE HOLE. DESCRIPTION: FOLLOW ON X-RAY POST OP VISIT DATE-2005/11/29 AE OUTCOME: RESOLVED; ADDITIONAL COMMENTS: RADIOGRAPH SHOWS STABILIZATION POST OP VISIT DATE-2010/11/17 AE ONSET DATE: 2010/01/01; AE DESCRIPTION: PT C/O DISCOMFORT BENEATH SHOULDER BLADE ON THE RIGHT WHICH CAN RADIATE DOWN INTO THE ARM TREATMENT: NO; ADDITIONAL TREATMENT: PT. IS PURSUING A STABLE COURSE AND IS NOT CONSIDERING FURTHER SURGERY. AE OUTCOME: RESOLVED; DESCRIPTION: CERVICAL XRAYS SHOW A STABLE FUSION. THERE IS STABLE DISLODGMENT OF ONE OF THE INFERIOR SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761220 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Other CERVICAL PLATE SYSTEM, SCREWS