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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE COROENT LC SYSTEM INTERVERTEBRAL BODY FUSION DEVICE

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NUVASIVE, INC. NUVASIVE COROENT LC SYSTEM INTERVERTEBRAL BODY FUSION DEVICE Back to Search Results
Model Number COROENT LC, 8X11X25
Device Problem Improper or Incorrect Procedure or Method
Event Date 08/31/2012
Event Type  Other  
Event Description

The intervertebral body device reportedly was placed during a tlif procedure at l4-l5 disc space. The surgery was completed and upon review of post operative ct scan it was decided that the placement was too posterior into the vertebral canal with the canal potentially being compromised. Revision surgery was completed the following day.

 
Manufacturer Narrative

(b)(4). Coroent lc, 8x11x25 8 degrees reportedly was placed during a l4-l5 tlif on friday august 31, 2012. Later in the evening the ct scan revealed that the implant was placed posterior into the vertebral canal with potentially compromising the vertebral canal. Ct scans were not made available to nuvasive. The surgeon brought the pt back the following day and decided to remove the implant and surgically widened the decompression and mitigated the need for a coroent implant. There was no pt injury and no related symptoms as a result of the placement or removal of this implant. The tlif surgical technique relies on identifying anatomical landmarks for successful placement of a coroent lc implant. It appears the surgeon was unsuccessful in his surgical technique and was unable to identify the final placement before concluding treatment of the pt. This resulted in the need for revision surgery the following day. There was no alleged product deficiency reported with this event.

 
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Brand NameNUVASIVE COROENT LC SYSTEM
Type of DeviceINTERVERTEBRAL BODY FUSION DEVICE
Manufacturer (Section D)
NUVASIVE, INC.
san diego CA
Manufacturer Contact
paul holbrook
7475 lusk blvd
san diego , CA 92121
8583205285
MDR Report Key2755748
Report Number2031966-2012-00044
Device Sequence Number1
Product CodeODP
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/17/2012,09/14/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/14/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCOROENT LC, 8X11X25
Device Catalogue Number6608125
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Hospital
Date Manufacturer Received09/04/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 09/14/2012 Patient Sequence Number: 1
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