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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE NUVASIVE RELINE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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NUVASIVE NUVASIVE RELINE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 16025540
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Cardiac Arrest (1762)
Date of Event 02/28/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
No product has been returned for investigation as no product malfunction has been alleged.No other event information has been reported.
 
Event or Problem Description
On (b)(6) 2019, patient underwent a posterior spinal fusion from th9-iliac levels.As per reporter when attempting to place a rod, patient went into cardiac arrest.Procedure was completed without placing a rod.On (b)(6) 2019, an additional procedure was performed, and rods were placed.No allegation of product malfunction reported.
 
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Brand Name
NUVASIVE RELINE SYSTEM
Common Device Name
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
NUVASIVE
7475 lusk boulevard
san diego CA 92121
MDR Report Key8448657
Report Number2031966-2019-00173
Device Sequence Number344685
Product Code NKB
UDI-Device Identifier00887517556264
UDI-Public887517556264
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K143684
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/01/2019
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 Number16025540
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 03/22/2019
Initial Report FDA Received Date03/25/2019
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;
Patient Age86 YR
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