NOVUS CT UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-03-02 for NOVUS CT UNK manufactured by Sofamor Danek.

Event Text Entries

[87469] The rptr was involved in a motor vehicle accident in 7-1996. After the accident, she was diagnosed as having degenerative bone disease and a "protruding disk" in her cervical spine. The rptr tried conventional treatments without success in an attempt to delay surgery as long as possible. On 3-13-1997, the rptr had a surgical procedure. Reportedly, a disk was "cut out" and the novus ct implant was placed. Immediately following surgery, the rptr states she began to experience problems which she believes are related to the implant. She was diagnosed as having more "protruding disks" in her cervical spine below the level of the implant. The symptoms the rptr has been experiencing includes loss of feeling in the digits of the rt hand, rt shoulder pain, hands which shake "like parkinson's disease", swollen and sore neck, and decreased range of motion in her neck. The rptr states her neck will become "stuck" if she turns her head to the extreme rt or lt and if she over extends her neck. The symptoms have progressively worsened. The rptr has been instructed to wear a neck brace "as much as possible" and to obtain physical therapy. The physical therapy according to the rptr worsened her symptoms. She stopped physical therapy two weeks ago after two mos of therapy. The rptr states she must sleep in a recliner at night with a pillow on either side of her head to decrease movement. The rptr has stopped working due to her worsening symptoms. She was referred for a nerve block, but the physician would not perform the procedure due to the risks involved.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1013063
MDR Report Key153461
Date Received1998-03-02
Date of Report1998-03-02
Date of Event1997-03-13
Date Added to Maude1998-03-03
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameNOVUS CT
Generic NameCERVICAL SPINE IMPLANT
Product CodeMPJ
Date Received1998-03-02
Model NumberUNK
Catalog NumberUNK
Lot NumberUNK
ID NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Implant FlagY
Date RemovedA
Device Sequence No1
Device Event Key149499
ManufacturerSOFAMOR DANEK
Manufacturer Address1800 PYRAMID PL. MEMPHIS TN 38132 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1998-03-02

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