BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 6809429 · Received August 22, 2017

    Report

    Report Number
    1030489-2017-01946
    Event Type
    Injury
    Date Received
    August 22, 2017
    Report Date
    February 13, 2019
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWQ
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    FOUR SCREWS WITH PART# 876-816 [510(K)- K970806, UDI- (B)(4)] AND ONE ANTERIOR CERVICAL PLATE WITH PART# 976-142 [510(K)- K021461 AND UDI- (B)(4)] WERE REPORTED FOR THE EVENT. IT IS UNKNOWN WHETHER THESE DEVICE CONTRIBUTED TO THE EVENT WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES ONLY. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: 68 MONTHS POST-OPERATIVELY, THE PATIENT REPORTED WORSENED LEFT UPPER CERVICAL PAIN ALONG WITH TENSION HEADACHES, DIFFICULTY SWALLOWING. THE PATIENT UNDERWENT A SURGERY FOR REMOVAL OF ADR AT C4-5, ANTERIOR CERVICAL FUSION C4-5, C7-T1 (STAGE 1 COMPLETE, STAGE 2 PENDING). THE PATIENT WAS DIAGNOSED WITH CERVICAL SPONDYLOSIS, HYPOLORDOSIS AND LATERAL STENOSIS. EVEN THOUGH REMOVAL OF ADR MADE SWALLOWING EASIER AND MUCH IMPROVED, PATIENT STILL HAD DIFFICULTY SWALLOWING AT 120 MONTHS POST-OP VISIT. 120 MONTHS POST-OPERATIVELY, THE PATIENT CONTINUES WITH UPPER NECK PAIN, TENSION AND HEADACHES AND UNDERWENT SURGICAL DECOMPRESSION AND FUSION AT C4-T2 (STAGE 2 COMPLETED).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT CERVICAL SURGERY AT C5-6 AND C6-7 USING EXTRAPHARYNGEAL ANTEROLATERAL APPROACH. APPROXIMATELY 165 DAYS/5 MONTH POST-OPERATIVELY, THE PATIENT HAD INCREASED NECK PAIN DUE TO FALL WHILE CARRYING WASTE BASKET. CT SCAN RESULTS ON (B)(6) 2007: CRANIOVERTEBRAL JUNCTION DEMONSTRATES MILD DEGENERATIVE OSTEOPHYTES. C5-6 SPACER WAS WELL POSITIONED, PERSISTENT LUCENCY WITHIN INFERIOR AND POSTERIOR ASPECT REPORTED. C6-7 SPACER WELL POSITIONED WITH LUCENCY ALONG SUPERIOR AND INTERIOR ASPECT. 14 MONTHS POST-OP, THE STUDY OF X-RAYS SHOWED NON-UNION AT C5-6, NECK PAIN CONTINUES. 423DAYS/14 MONTHS POST-OPERATIVELY,MRI STUDY SHOWS NON UNION AT C5-6. 18 MONTHS POST-OP, THE PATIENT UNDERWENT REVISION OF C5-6, C6-7 ANTERIOR CERVICAL DISCECTOMY AND FUSION, C4-5 ARTIFICIAL DISC REPLACEMENT, REMOVAL OF PLATE AT C5-6, C6-7, REMOVAL OF C5-6 INTERBODY GRAFT, REPLACED C5-6 INTERBODY ALONG WITH HYDRASORB AND BONE MORPHOGENIC PROTEIN, RE-PLATED C5-7, ANTERIOR PLACEMENT OF CERVICAL DISC AT C4-5. 21 MONTHS POST-OPERATIVELY,PATIENT WAS REPORTED TO BE IMPROVING WITH SOME REMAINING NECK PAIN RIGHT SIDE GREATER THAN LEFT.NO ARM PAIN. 24 MONTHS POST-OPERATIVELY, PATIENT CONTINUES ON PAIN MEDICINES AND EXCERCISES BUT CONTINUES HAVING BILATERAL TIGHTNESS INTO CERVICAL PARAVERTEBRAL MUSCLES AND SUBOCCIPITAL REGION. 37 MONTHS POST-OPERATIVELY, X-RAYS DONE ON (B)(6) 2010 SHOWS C5-C7 FULLY FUSED AND GOOD PLACEMENT AND MOVEMENT AT ADR LEVEL. OUTCOME: RESOLVED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591855 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWQ WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention