BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 4271830 · Received November 23, 2014

    Report

    Report Number
    1030489-2014-04540
    Event Type
    Injury
    Date Received
    November 23, 2014
    Date of Event
    April 1, 2004
    Report Date
    January 24, 2009
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWQ
    PMA / PMN Number
    K081038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): UNK DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: 876-313 / LOT: UNKNOWN (X4) 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-2004/04/09 AE ONSET DATE: 2004/04/01 AE DESCRIPTION: C/O UNRESOLVED NECK PAIN MEDICATION: YES OTHER TREATMENT: CT MYELOGRAM ADDITIONAL TREATMENT: CT MYELOGRAM ON 4/6/04DEMONSTRATED A PROMINENT C5-6 VENTRAL EXTERNAL IMPRESSION AND C5-6 SPURS C6-7 SPUR / BULGE COMPLEX WITH THECAL SAC ENCROACHMENT AND CORD DEFORMITY DESCRIPTION: NO NEUROSURGICAL INTERVENTION AT THIS TIME POST OP VISIT DATE-2005/04/08 TREATMENT: NO AE OUTCOME: RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759122 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00030 YR Other CERVICAL PLATE SYSTEM, SCREWS