MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE PRECEPT SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 8800000006

Device Problem Detachment Of Device Component (1104)

Patient Problem Failure of Implant (1924)

Event Date 02/18/2016

Event Type  malfunction  

Manufacturer Narrative

Radiographs received confirmed the separation of three lock screws.The patient underwent revision surgery with no reported complications.No further investigation can be completed at this time.Root cause has not been determined, no conclusion can be drawn.Review of labeling notes: potential adverse events and complications: "potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)and loss of fixation." warnings, cautions and precautions: "confirm heights of screws match with patient's lordosis when securing lock screws.Failure to verify screw height following insertion may result in inadequate rod normalization." "final-tighten all lock screws with the counter-torque and torque t-handle.Do not final-tighten through other instruments in the set, as the rod may not be able to normalize to the tulip.Ensure there is enough rod overhang when final tightening, and do not lock down on the conical portion of the rod.Failure to do so may lead to improper lock down of the construct.It may be necessary for the surgeon to add length to the rod, depending upon patient anatomy and desired lordosis." not returned.

Event Description

In (b)(6) 2016, a female patient underwent posterior fixation at l3-l4 to treat vertebral osteomyelitis.On (b)(6) 2016 surgeon reported that radiographs showed three set screws had disassociated from the construct.Revision surgery was performed on (b)(6) 2016 and the fixation was extended to s2.Patient is reported as doing well after revision surgery.

• Brand Name: NUVASIVE PRECEPT SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: stacy gregory ; 7475 lusk blvd; san diego, CA 92121 ; 8587360313
• MDR Report Key: 5498372
• MDR Text Key: 40252374
• Report Number: 2031966-2016-00019
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 8800000006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR