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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE RELINE SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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NUVASIVE, INCORPORATED NUVASIVE RELINE SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Ulcer (2274)
Event Date 09/08/2021
Event Type  Injury  
Manufacturer Narrative
No device was returned as no product malfunction was suggested. No images were provided to confirm the complaint. Due to the lack of information the root cause cannot be determined however review of the provided information suggests the patient's lack of mobility and anatomical condition may be the cause or contributor. No additional investigation can be completed at this time. Labeling review: "potential adverse events and complications: as with any major surgical procedures, there are risks involved in orthopedic surgery. Infrequent operative and postoperative complications that may result in the need for additional surgeries include: early or late infection. Potential risks identified with the use of this system, which may require additional surgery, include: infection. " "warnings, cautions and precautions: care should be taken to insure that all components are ideally fixated prior to closure. " "pre-operative warnings: care should be used during surgical procedures to prevent damage to the devices and injury to the patient. ".
 
Event Description
On (b)(6) 2021 a patient underwent a spinal procedure at t9/l1. On (b)(6) 2021 it was reported that the patient had decubitus ulcers at right l1. On (b)(6) 2021 a revision surgery was conducted to remove the screw at right l1. No radiographs were provided and no additional injuries were reported.
 
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Brand NameNUVASIVE RELINE SYSTEM
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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 Key12514050
MDR Text Key272742018
Report Number2031966-2021-00127
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K182974
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/08/2021
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: 09/22/2021 Patient Sequence Number: 1
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