BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 2933654 · Received January 29, 2013

    Report

    Report Number
    1030489-2013-00291
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    April 1, 2010
    Report Date
    January 2, 2013
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWQ
    PMA / PMN Number
    K081038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: STEVE W. CHANG, MD ET AL. FOUR-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION WITH PLATE FIXATION: RADIOGRAPHIC AND CLINICAL RESULTS. J NEUROSURG SPINE, 2010, VOLUME 66, NUMBER 4. AGE AT TIME OF EVENT: MEAN AGE, (B)(6); AGE RANGE, (B)(6). SEX: 19 FEMALES, 15 MALES. (B)(6). (B)(4). NEITHER DEVICE NOR APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    THIRTY-FOUR PATIENTS (19 FEMALES, 15 MALES; MEAN AGE, (B)(6); AGE RANGE, (B)(6)) WHO UNDERWENT 4-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION WITH PLATING OVER 10 YEARS (1997-2006) WERE IDENTIFIED RETROSPECTIVELY FROM A SURGICAL DATABASE. ONLY PATIENTS UNDERGOING SURGERY AT 4 CONTIGUOUS DISC LEVELS WERE INCLUDED. PATIENTS UNDERGOING CORPECTOMY AT ANY OF THE INTERVENING LEVELS WERE EXCLUDED FROM THE ANALYSIS; THAT IS, ALL HYBRID CONSTRUCTS WERE EXCLUDED. THE MOST COMMON INDICATION WAS CERVICAL MYELOPATHY, FOLLOWED BY A LOSS OF CERVICAL LORDOSIS, AXIAL NECK PAIN, RADICULOPATHY, SEGMENTAL INSTABILITY, RADICULOMYELOPATHY, POSTLAMINECTOMY DEFORMITY, FAILURE OF PREVIOUS FUSION, AND CENTRAL CORD SYNDROME. TWENTY-NINE PATIENTS UNDERWENT FUSION AT C3-C7, 4 PATIENTS AT C4-T1, AND 1 PATIENT AT C2-C6. THIRTY-ONE PATIENTS UNDERWENT INSTRUMENTED FUSION WITH SEMI-CONSTRAINED PLATING SYSTEMS. THREE PATIENTS UNDERWENT FUSION WITH A FULLY CONSTRAINED PLATE. FIBULAR ALLOGRAFT RING WAS PLACED IN 26 OF THE 34 PATIENTS. AT THE SURGEON¿S DISCRETION, 8 PATIENTS UNDERWENT ILIAC CREST HARVEST FOR AUTOLOGOUS FUSION, TYPICALLY BECAUSE THE INTRINSIC QUALITY OF THE PATIENT'S BONE WAS POOR. IN CONCLUSION FOUR-LEVEL DISCECTOMY WITH PLATING CAN BE ASSOCIATED WITH A HIGH RATE OF FUSION (92.6%). THE TECHNIQUE IS SAFE AND EFFECTIVE FOR MANAGING MULTILEVEL CERVICAL SPONDYLOTIC MYELOPATHY AND OBVIATES THE NEED FOR THE STAGED CIRCUMFERENTIAL PROCEDURES THAT ROUTINELY FOLLOW 3-LEVEL CORPECTOMIES. THE MOST COMMON MINOR COMPLICATION WAS TRANSIENT DYSPHAGIA, WHICH OCCURRED IN 18 PATIENTS (53%) AND PERSISTED A MEAN OF 1.5 MONTHS. ONE OF THESE 18 PATIENTS HAD LONG-TERM DYSPHAGIA AND REQUIRED PLACEMENT OF A GASTROSTOMY TUBE 1 MONTH AFTER SURGERY. THE GASTROSTOMY TUBE WAS REMOVED 3 MONTHS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39205 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ WARSAW ORTHOPEDICS NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention