BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 2210044 · Received August 12, 2011

    Report

    Report Number
    1030489-2011-01045
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K063100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PLATE WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION CONFIRMS IMPLANT ASSEMBLY SEPARATED. OPTICAL AND MICROSCOPIC EXAMINATION OF THE IMPLANT REVEALS RATCHET SPRING POCKET BROKEN, AND WALL BOWED. FRACTURE SURFACE PROVIDES SOME EVIDENCE OF FATIGUE. IMPLANT END COMPONENT RATCHETING CATCH FEATURE EXAMINATION REVEALS SIGNIFICANT WITNESS MARKS AND GOUGING, THE NATURE AND DIRECTION OF DAMAGE IS CONSISTENT WITH TENSILE OVERLOAD IN THE FULLY CLOSED POSITION. OBSERVATIONS ARE SIMILAR TO OBSERVATIONS OF TENSILE FAILURES FOUND IN (B)(4). ASYMMETRICAL ABRASIONS NOTED ON SLIDE AREA OF COMPONENT WHICH INTERFACES WITH END COMPONENT, SUGGESTING TENSILE LOAD MAY HAVE BEEN OFF CENTER AXIS OF IMPLANT. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    IMPLANTED IN 2009. MONTH AND DAY NOT REPORTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY FUSION AT C4-6. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO NON-UNION. WHEN THE PLATE WAS EXPLANTED, IT CAME OUT IN TWO PIECES, THE BROKEN SEGMENT OCCURRED AT THE LEVEL OF THE NON-UNION. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE PATIENT¿S MEDICAL RECORDS THAT THE PATIENT PRESENTED TO SURGERY WITH CERVICAL ANTERIOR PSEUDOARTHROSIS AT C4-C5 AND ADJACENT SEGMENT DISEASE AT C6-C7, POST PRIOR CERVICAL PROCEDURES FOR C4-5 AND C5-6 ACDF. THE PATIENT UNDERWENT A PROCEDURE FOR ANTERIOR REMOVAL OF SPINAL HARDWARE, EXPLORATION OF FUSION, C4-C5 OSTEOTOMY, REPAIR OF C4-C5 PSEUDOARTHROSIS, C6-C7 DISCECTOMY WITH BILATERAL FORAMINOTOMY C4-5 AND C6-7, PARTIAL C4 AND C5 CORPECTOMY, RECONSTRUCTION WITH LEFT STRUCTURAL ILIAC CREST BONE GRAFT, CORNERSTONE ALLOGRAFT, AND ANTERIOR SEGMENTAL PLATING FROM C4-C7, FUSION C4-C7. NOTES INDICATE THAT DURING REMOVAL OF THE ANTERIOR PLATE, THE PLATE WAS FOUND TO BE BROKEN AT THE DYNAMIC PORTION. NOTES ALSO INDICATE THERE WAS A LARGE AMOUNT OF ANTERIOR FAT AND CORROSION OVER THE SOFT TISSUE, LEAVING IT BLACK, WHICH THIS TISSUE WAS CAREFULLY DISSECTED AWAY FROM THE NORMAL TISSUE AND THEN EXCISED AND SENT FOR CULTURE. CULTURE NOTES INDICATE ¿DENSE FIBROUS CONNECTIVE TISSUE WITH PIGMENT DEPOSITION¿.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED BY THE PATIENT'S ATTORNEY INDICATES THAT "THE PLATE HAD BROKEN, ADHERED TO PLAINTIFFS ESOPHAGUS, AND LEFT SHARDS OF TITANIUM IN HIS SPINE. PLAINTIFF IS LEFT WITH CHRONIC NECK AND SHOULDER PAIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ WARSAW ORTHOPEDIC, INC. NA 0049013W

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention