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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WARSAW ORTHOPEDIC, INC. BRYAN CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC

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WARSAW ORTHOPEDIC, INC. BRYAN CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC Back to Search Results
Catalog Number 6470117C
Device Problem Insufficient Information (3190)
Patient Problem Neck Pain (2433)
Event Date 11/01/2004
Event Type  Injury  
Event Description

It was reported that the patient involved in the clinical study underwent a procedure for implant of an artificial cervical disc at c6-c7. Approximately 6 months postoperatively, the patient had a new onset of axial neck pain at the base of the neck. A medrol dosepak and aerobic exercise were recommended. At the 12 month postoperative evaluation, the patient continued to complain of axial neck pain. The patient had neck pain pre-operatively and had many levels with arthritis, other than the treated level. The investigator believed it was one of those other levels that were causing the pain. At the 24 month postoperative evaluation, the patient continued to complain of axial neck pain. No treatment was provided. The investigator stated this was probably not related to the device as the patient has many levels of arthritis other than the treated level. Approximately 36 months postoperatively, the patient reported numbness in arms when moving neck and also complained of shoulder pain. The patient received injections of local anesthetics and steroids in the right shoulder, an ultrasound of the bilateral shoulder, and an mri of the cervical spine was obtained as well. The patient was also referred to a specialist and physical therapy was recommended. At the 60 month postoperative evaluation, the patient had axial neck pain with radiating pain to the left shoulder and arm. Treatment included vicodin and lyrica. The investigator noted the event was probably not related to the cervical disc prosthesis as the patient had c4-c5 and c5-c6 spondylosis. The patient had worsening neck pain radiating into his left shoulder and arm. The patient noted a pulsation-type sensation in his hands along with constant left arm tremor that occurred with a ¿charley horse¿ feeling. Approximately 73 months postoperatively, a plain x-ray was performed, results not provided. Emg/ncs revealed an acute left c5 radiculopathy and chronic bilateral c6 radiculopathy. An mri revealed multilevel degenerative changes mostly notable at c4-c5 which demonstrated moderate foraminal narrowing bilaterally as well as mild central canal stenosis. One month later, ct scan revealed mild to moderate degenerative changes, worse at the levels of c2-c3, c3-c4, and c4-c5. Approximately 75 months postoperatively, the patient underwent an anterior cervical discectomy and arthroplasty at c5-c6 with a synthes prodisc-c device; anterior cervical discectomy at c4-c5; anterior cervical fusion at c4-c5; anterior cervical plating at c4-c5 with a biomet maxan plate; structural allo prefabricated 8mm graft with extra-extra small bmp grafting; and local autologous bone grafting. From the operative note, the preoperative and postoperative diagnoses was cervical spondylosis with radiculopathy, c4 through c6, status post anterior cervical discectomy and arthroplasty with an artificial disk replacement at c6-c7. The patient was discharged the day after surgery. The patient returned for post-operative follow-up care. Approximately 99 months postoperatively, the x-rays revealed unchanged c4-c5 discectomy and anterior instrumented fusion procedure without evidence of implant failure. There was no appreciable motion at c4-c5. There was normal motion of the disc prosthesis at c5-c6 and c6-c7. There was minimal motion between c2-c4 and mild degenerative disease at c2-c3 and c4-c5. Approximately 118 months postoperatively, the patient continued to have worsening neck pain that radiates to the left shoulder and arm. The patient noted a pulsation-type sensation in his hands along with constant left arm tremor that occurred with a ¿charley horse¿ feeling. Treatment included exalgo 8 mg daily, dilaudid 4mg prn, norco 325/5 mg prn, soma 350mg prn. The investigator noted this event was possibly related to the prosthesis as this patient ¿has adjacent level breakdown that required surgery¿. The outcome of this event is considered pending. Approximately 73 months postoperatively, the patient was diagnosed with diaphragm paralysis. A ¿redy¿/fluoroscopy revealed paradoxical movement of the elevated left diaphragm, corresponding to paralysis. No additional treatment was provided. Approximately 119 months postoperatively, the patient continued to have diaphragm paralysis. No treatment was provided. No diagnostic procedure was performed. The investigator noted this event was probably not related to the prosthesis as it was ¿unlikely that the left diaphragmatic paralysis was related to c-spine but could be a possibility¿. The outcome of this event is considered pending. Approximately 69 months postoperatively, the patient complained of left shoulder pain. Approximately 72 months postoperatively, an x-ray revealed a mild glenohumeral and acromioclavicular joint osteoarthritis. Left shoulder ultrasound revealed atrophy of the supraspinatus and infraspinatus muscle without a rotator cuff tear. Treatment included medications, physical therapy and a left shoulder injection with 2cc¿s of kenalog 40mg. The findings were consistent with a mild frozen shoulder. At the 84 month postoperative evaluation, the patient would be followed to assess his range of motion. Approximately 93 months postoperatively, treatment included c7-t1 epidural steroid injection into neck and shoulder with lidocaine and triamcinolone. Approximately 119 months postoperatively, the patient continued to have left shoulder pain. The investigator noted, the findings were consistent with a mild frozen shoulder. No diagnostic procedure was performed. The investigator noted this event was probably not related to the prosthesis as ¿there was a chance that his shoulder pain could be related to his c-spine¿. The outcome of this event is considered pending.

 
Manufacturer Narrative

(b)(4). Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.

 
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Brand NameBRYAN CERVICAL DISC SYSTEM
Type of DevicePROSTHESIS, INTERVERTEBRAL DISC
Manufacturer (Section D)
WARSAW ORTHOPEDIC, INC.
2500 silveus crossing
warsaw IN 46582
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
Manufacturer Contact
huzefa mamoola
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key3781400
MDR Text Key18933801
Report Number1030489-2014-02360
Device Sequence Number1
Product Code MJO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP060023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/17/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/30/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6470117C
Device LOT Number221-02325
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/17/2014
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/30/2014 Patient Sequence Number: 1
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