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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 8848160006
Device Problem Misassembled During Installation (4049)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/01/2021
Event Type  malfunction  
Manufacturer Narrative
No product was returned for evaluation and no radiographs could be provided confirming the event. 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. In (b)(6) 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, causing the screw loosening. On (b)(6)2021 a revision occurred where the loose screw was replaced with a new screw, and the fixation level was extended one vertebra to the cranial side. Reportedly the operation was successfully completed and the patient has been recovering.
 
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Brand NameNUVASIVE PRECEPT SPINAL 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 Key12318962
MDR Text Key266639245
Report Number2031966-2021-00095
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00887517314604
UDI-Public887517314604
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K171894
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 08/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8848160006
Device Lot NumberCT5156
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 Received07/14/2021
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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