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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE COHERE THORACOLUMBAR INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

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NUVASIVE, INCORPORATED NUVASIVE COHERE THORACOLUMBAR INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR Back to Search Results
Model Number 6941238
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Laceration(s) (1946)
Event Date 07/26/2022
Event Type  Injury  
Manufacturer Narrative
There was no product returned for evaluation, as no product malfunction was alleged or identified.Review of the provided information identified a surgical error took place causing an incidental durotomy unrelated to nuvasive product functionality.No additional investigation needed.Labeling review: "warnings, cautions, and precautions: dural leak in cases of excessive load application or impingement of close vessels, nerves, and or organs by slippage or misplacement of the instrument." "potential adverse events and complications: infrequent operative and postoperative complications that may result in the need for additional surgeries.Potential risks identified with the use of this system, which may require additional surgery include neurological, vascular or visceral injury, dural leak.¿ "pre-operative warnings: care should be used during surgical procedures to prevent damage to the devices and injury to the patient." "intra-operative warnings: the physician should take precautions against putting undue stress on the spinal area with instruments.Any surgical technique should be carefully followed.It is important that the surgeon exercise extreme caution when working in close proximity to vital organs, nerves, or vessels, and that the force applied to the instrumentation is not excessive to prevent potential injury to the patient." device still in-situ.
 
Event Description
It was reported on a clinical study that on (b)(6) 2022 a patient underwent a transforaminal interbody fusion.The surgeon identified a small incidental durotomy that took place during surgery where the ligamentum had adhered to the dura.A duragen patch was placed and covered with adherus.There was no extravasation after the repair.
 
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Brand Name
NUVASIVE COHERE THORACOLUMBAR INTERBODY SYSTEM
Type of Device
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
Manufacturer (Section D)
NUVASIVE, INCORPORATED
7475 lusk boulevard
san diego CA 92121
Manufacturer (Section G)
NUVASIVE, INCORPORATED
7475 lusk boulevard
san diego CA 92121
Manufacturer Contact
geoff gannon
7475 lusk boulevard
san diego, CA 92121
MDR Report Key15810321
MDR Text Key303793869
Report Number2031966-2022-00257
Device Sequence Number1
Product Code MAX
UDI-Device Identifier00887517398475
UDI-Public887517398475
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K203714
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 11/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number6941238
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/27/2022
Initial Date FDA Received11/16/2022
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 Sequence Number1
Patient Outcome(s) Other;
Patient Age71 YR
Patient SexFemale
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