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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 Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Embolism/Embolus (4438)
Event Date 02/25/2022
Event Type  Injury  
Event Description
On (b)(6) 2022 a underwent a extreme lateral interbody fusion procedure from l1-l5 where a competitors cages were implanted. On (b)(6) 2022 the secondary portion of the extreme lateral interbody fusion procedure occurred from t10-s2ai where a nuvasive reline construct was installed while two additional competitor¿s cages were inserted. At an unknown date post op it was reported that the patient complained of pain in the left leg and while in the standing position. As a consequence on (b)(6) 2022 patient had a revision surgery where a blood clot near the midline of l4/5 was removed. The patient is reported to no longer in pain after the revision surgery.
 
Manufacturer Narrative
No product was received or returned as no product malfunction was reported and the involved devices currently remain in situ. No radiographs or testing data was provided confirming the reported blood clot. The root cause of the event is unknown but could be the result of inadvertent contact and tissue damage. Note nuvasive posterior fixation was utilized in conjunction with another manufactures cages and likely is a cause or contributor, and is considered to be off label usage. No additional investigation can be completed at this time. Label 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: damage to blood vessels. " ". Potential risks identified with the use of this system, which may require additional surgery, include: neurological, vascular or visceral injury, pain, discomfort or abnormal sensations due to the presence of the device. " ". 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. " ". Compatibility: do not use the reline system with components of other systems, other than the armada system. Refer to the armada system instructions for use for a list of the armada system indications for use. Unless stated otherwise, nuvasive devices are not to be combined with the components of another system. All implants should be used only with the appropriately designated instrument (reference surgical technique)¿".
 
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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 Key13869594
MDR Text Key293080276
Report Number2031966-2022-00061
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K143684
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2022
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
Date Manufacturer Received02/25/2022
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 Treatment Data
Date Received: 03/23/2022 Patient Sequence Number: 1
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