BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 4275362 · Received November 25, 2014

    Report

    Report Number
    1030489-2014-04561
    Event Type
    Injury
    Date Received
    November 25, 2014
    Date of Event
    September 1, 2007
    Report Date
    January 24, 2009
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWQ
    PMA / PMN Number
    K081038
    Adverse Event
    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: 876-314 / LOT: UNKNOWN (X2) PART: 876-014 / 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-2004/10/04 AE ONSET DATE: 2004/10/01; AE DESCRIPTION: NOTED HALO EFFECT @ INFERIOR / SUPERIOR GRAFT SITE ON CERVICAL XRAY INDICATING POOR INCORPORATION OF FUSION (PSEUDOARTHROSIS) OTHER TREATMENT: BONE GROWTH STIMULATOR ADDITIONAL TREATMENT: BONE GROWTH STIMULATOR POST OP VISIT DATE-2005/02/17 OTHER TREATMENT: BONE GROWTH STIMULATOR AE OUTCOME: RESOLVED; DESCRIPTION: INCREASED BONE GROWTH C GRAFT SITE. D/C GROWTH STIMULATOR POST OP VISIT DATE-2008/01/29 AE ONSET DATE: (B)(6) 2007; AE DESCRIPTION: PT. STARTED HAVING LEFT SIDED NECK PAIN-REPORTED TO PCP ON 12/23/07 AND RECEIVED A DEMEROL/MUSCLE RELAXANT IM AND SCRIPTS FOR TYLENOL #4 AND SOMA-NO XRAYS TAKEN @ PCP OFFICE MEDICATION: YES;REFERRED TO SPECIALIST: YES; ADDITIONAL TREATMENT: ARNP IS QUESTIONING PSEUDOARTHROSIS AND IS REQUESTING A BONE SCAN POST OP VISIT DATE-2009/05/19 MEDICATION: YES; ADDITIONAL TREATMENT: PT. CONTINUES TO TAKE TYLENOL #4 PRN AND SOMA BID DESCRIPTION: PT. STATES THE PAIN IS ABOUT THE SAME HIS X-RAY SHOWS STABLE POSITION OF HIS PLATE WITH STILL SUSPECTED INCOMPLETE FUSION AT C6-7 ; ADDITIONAL COMMENTS: INSURANCE WOULD NOT COVER THE REQUESTED BONE SCAN. NO FURTHER TESTING HAS BEEN DONE. POST OP VISIT DATE-2011/02/01 MEDICATION: YES; ADDITIONAL TREATMENT: PT TAKES SOMA 350MG BID DESCRIPTION: PT STATES NECK PAIN IS "STILL THERE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763710 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Required Intervention CERVICAL PLATE SYSTEM, SCREWS