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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEKATLANTIS ANTERIOR CERVICAL PLATE SYSTEMAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

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MEDTRONIC SOFAMOR DANEK ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY   Back to Search Results
Catalog Number 876-137
Event Date 12/02/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(6). (b)(4).

 
Event Description

It was reported that a patient received a c5-c6 and c6-c7 bi-level anterior cervical discectomy and fusion with cortical ring allografts and a cervical plate system. It was reported that approximately 35 months postoperatively, the patient complained of neck pain. Treatment included skelaxin 800mg. Approximately 38 months postoperatively, the patient had a ct scan which showed pseudoarthrosis at c5-c6. Treatment included skelaxin, ibuprofen, celebrex, tylenol and flexeril. Approximately 39 months postoperatively, a thin ct was ordered. Approximately 44 months postoperatively, the patient had a c5-c6 posterior fusion and posterolateral mass screws, rods, and bmp. Additional treatment included norco 10 quantity 60 and a medrol dose pak. No further patient complications were reported.

 
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Brand NameATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
Type of DeviceAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Manufacturer (Section F)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
Manufacturer Contact
huzefa mamoola
1800 pyramid place
memphis , TN 38132
(901) 396 -3133
Device Event Key3006852
MDR Report Key2981561
Event Key2878075
Report Number1030489-2013-00642
Device Sequence Number1
Product CodeKWQ
Report Source Manufacturer
Source Type Health Professional,Study
Reporter Occupation Physician
Type of Report Initial
Report Date 01/29/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/27/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number876-137
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Device Age
Was The Report Sent To Manufacturer? No
Date Manufacturer Received01/29/2013
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/27/2013 Patient Sequence Number: 1
#TreatmentTreatment Date
CORTICAL RING ALLOGRFTS, 4X13 SELF DRILL VA SCREWS
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