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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 10000425
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/27/2020
Event Type  malfunction  
Manufacturer Narrative
Product was returned and examined and the root cause of the failure could not be established.Review of the device history record notes no material non-conformance¿s, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to this mode of failure.Even though root cause could not be confirmed, the fracture of the tap driver was consistent with off-angled and/or excessive force possibly from sclerotic bone.Labeling review: ".Warnings, cautions and precautions: the implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.".
 
Event Description
On (b)(6) 2020, patient underwent a two part procedure.First an extreme lateral interbody fusion at l2/3 levels and second, same day a percutaneous posterior fixation.It was reported that a tap driver fractured when a physician was inserting it at the l4 level.The physician tried to remove the piece, however he could not retrieve it.The physician changed the procedure from the percutaneous pedicle screw to an open procedure where the piece was removed.
 
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Brand Name
NUVASIVE RELINE SYSTEM
Type of Device
THORACOLUMBOSACRAL 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
virnalisa cobacha
7475 lusk boulevard
san diego, CA 92121
MDR Report Key10462657
MDR Text Key205670626
Report Number2031966-2020-00170
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00887517511225
UDI-Public887517511225
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K160989
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 08/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number10000425
Device Lot NumberNG79401
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/28/2020
Initial Date FDA Received08/27/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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