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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE COROENT SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
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NUVASIVE, INCORPORATED NUVASIVE COROENT SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR Back to Search Results
Model Number 7151260
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Post Operative Wound Infection (2446)
Date of Event 03/30/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
No product has been returned for investigation as no product malfunction was alleged.No root cause can be determined at this time.Potential adverse events and complications ".As with any major surgical procedures, there are risks involved in spinal/orthopedic surgery.Potential risks identified with the use of this system, which may require additional surgery, include: infection." product still in-situ.
 
Event or Problem Description
On (b)(6) 2020 a patient underwent a lumbar fusion spinal procedure.Postoperatively, the patient developed a superficial wound infection.Patient was treated with iv abx and underwent i&d (incision and debridement).
 
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Brand Name
NUVASIVE COROENT SYSTEM
Common Device Name
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
Manufacturer (Section D)
NUVASIVE, INCORPORATED
7475 lusk boulevard
san diego CA 92121
MDR Report Key10084330
Report Number2031966-2020-00090
Device Sequence Number19512759
Product Code MAX
UDI-Device Identifier00887517231796
UDI-Public887517231796
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K141665
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/19/2020
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
Operator of Device Health Professional
Device Model Number7151260
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/30/2020
Initial Report FDA Received Date05/22/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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