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U.S. Department of Health and Human Services

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

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NUVASIVE, INC. NUVASIVE COROENT SYSTEM INTERVERTEBRAL FUSION DEVICE Back to Search Results
Model Number 1719035
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Paralysis (1997); Paraplegia (2448)
Event Date 03/17/2015
Event Type  Injury  
Event Description

On (b)(6) 2015, the surgeon was performing a lateral interbody fusion from l5-t10. During placement of the interbody cage at t11-12 the pt sustained paralysis at t11-12 spine level. It was reported that the pt had challenging anatomical characteristics including osteoporosis, a high iliac crest, low rib shape/configuration at l1-l2, critical positioning of the aorta in the thoracic spine, and severe concavity of the endplate at t11-12. These characteristics resulted in difficult retractor placement requiring use of the 4th retractor blade attachment in an effort to protect the aorta. The concavity noted at t11-12 caused further difficulty in placement of the interbody implant resulting in malplacement posteriorly compressing the spine canal. This resulted in the paralysis of the pt. It was noted that a confirmatory fluoroscopic film was not taken when the trial was inserted.

 
Manufacturer Narrative

(b)(4). No radiographs confirming the event were received. Device remains in-situ and no further investigation can be completed at this time. Pt condition and status of health prior to event is unk. The root cause of this reported event appeared to be the challenging anatomy and lack of constant monitoring via fluoroscopy to ensure appropriate/accurate placement of the interbody device. Review of labeling notes: warnings, cautions, and precautions: "potential risks identified with the use of this device system, which may require additional surgery, include: device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury. ".

 
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Brand NameNUVASIVE COROENT SYSTEM
Type of DeviceINTERVERTEBRAL FUSION DEVICE
Manufacturer (Section D)
NUVASIVE, INC.
7475 lusk blvd
san diego CA
Manufacturer Contact
paul holbrook
7475 lusk blvd
san diego, CA 92121
8583205285
MDR Report Key4713367
MDR Text Key5667966
Report Number2031966-2015-00022
Device Sequence Number1
Product Code MAX
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK141665
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/14/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/15/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Device MODEL Number1719035
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/17/2015
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: 04/15/2015 Patient Sequence Number: 1
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