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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
Model Number 12360500
Device Problem Misassembled During Installation (4049)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/29/2021
Event Type  malfunction  
Manufacturer Narrative
No product was returned as the explanted device was disposed of at the facility. No radiographs were provided confirming the device failure. The patient is recovering well post revision. Review of the provided information suggests the root cause of the issue is user error during installation as it was admitted that the device was misassembled during installation. No additional investigation can be completed. "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. Potential risks identified with the use of this system, which may require additional surgery, include:. Bending, fracture or loosening of implant component(s). Loss of fixation. " ". 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. ".
 
Event Description
On (b)(6) 2021 a patient underwent a posterior fixation procedure from t10-l5. In july on a unknown date during a routine post op follow up a radiograph revealed that the that the rod was installed in reverse against the curvature. According to information received, the bent rod was almost straight and so the screws were not loose and the patient had no pain. On (b)(6) 2021 a revision occurred where the device was replaced with a new rod. The revision operation was successfully completed and the patient is recovering well.
 
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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 lucas
7475 lusk boulevard
san diego, CA 92121
MDR Report Key12345295
MDR Text Key267453462
Report Number2031966-2021-00102
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00887517507648
UDI-Public887517507648
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K143684
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 08/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number12360500
Device Lot NumberCT144476
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 Received07/29/2021
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?
Type of Device Usage Initial

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