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U.S. Department of Health and Human Services

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

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NUVASIVE, INCORPORATED NUVASIVE PRECEPT SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 8806555006
Device Problem Installation-Related Problem (2965)
Patient Problem Unspecified Vascular Problem (4441)
Event Date 07/07/2021
Event Type  Injury  
Manufacturer Narrative

No product was returned for evaluation. No radiographs were provided to confirm the complaint. Review of the reported information suggests possible malplacement of pedicle screw resulting in breach and suggested vascular damage as the root cause. No additional investigation required. Labeling review: ". Potential adverse events and complications: as with any major surgical procedures, there are risks involved in orthopedic surgery. Potential risks identified with the use of this system, which may require additional surgery, include: neurological, vascular or visceral injury. " ". Warnings, cautions and precautions: the implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient. Correct selection of the implant is extremely important. The potential for success is increased by the selection of the proper size of the implant. While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants. 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 t8/l1. Immediate post-operative ct image showed the spinal screw at left l1 might have protruded forward but the surgeon decided to keep it as is. On an unknown date in (b)(6) 2021 during a follow-up a ct and mri revealed that the left l1 screw was in contact with the aorta. On another unknown date in (b)(6) 2021 a revision surgery was conducted due to possible vascular damage and both screws at l1 were replaced. No additional injuries reported.

 
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Brand NameNUVASIVE PRECEPT SPINAL SYSTEM
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
NUVASIVE, INCORPORATED
7475 lusk blvd.
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 Key12331684
MDR Text Key266894377
Report Number2031966-2021-00096
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK171894
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 08/17/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/17/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number8806555006
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 Received07/26/2021
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: 08/17/2021 Patient Sequence Number: 1
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