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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 13550000
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/02/2021
Event Type  malfunction  
Manufacturer Narrative
No product was received as the involved materials remain in-situ and no radiographs could be provided confirming the alleged issue. The lock screws were tightened off by hand and the surgeon failed to completed final tightening with the 90in-lb torque handle. The root cause of the issue it incorrect procedural method as all of the lock screws are required to be tightened using counter-torque and torque t-handles. No additional investigation will take place. 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. " "all lock screws should be final-tightened with the counter-torque and torque t-handle. Do not final-tighten through compression instruments (e. G. C/d rack and figure 8 compressor) in the set, as the rod may not be able to normalize to the tulip. ".
 
Event Description
On (b)(6) 2021 a patient underwent a spondylectomy procedure at l3 with posterior fixation from t12 to l5. The surgery was completed without issue. Within 1-2 hours after the surgery the physician stated that the construct lock screw were not torqued off. For unknown reasons during the initial procedure the screws were only hand tightened. On (b)(6) 2021 a revision occurred were the screws were all retightened with a torque handle. The patient is/was asymptomatic and it reported to be recovering.
 
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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 Key13176294
MDR Text Key283319156
Report Number2031966-2022-00004
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00887517551702
UDI-Public887517551702
Combination Product (y/n)N
Reporter Country CodeAS
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 01/06/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number13550000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/13/2021
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

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