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

Model Number	8896550
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiograph confirmed the event.The revision surgery occurred (b)(6) 2016.The shank head attached to the tulip was removed and has not returned for evaluation.The screw shank remains in-situ.The duration to failure is greater than one year; the fracture may have occurred as a result of fatigue due to non-union or high pre-load on the construct.No interbody implants were noted in the radiograph.Patient activity levels are unknown.No further evaluation can be performed at this time.Review of labeling notes: warning cautions and precautions "potential risks identified with the use of this device system, which may require additional surgery include: device component fracture, bending or loosening of implant, loss of fixation, fracture of the vertebra and visceral injury.If healing is delayed, or does not occur, the implant may eventually loosen, bend or break.Loads on the device produced by load bearing and by the patient's activity level will dictate the longevity of the implant.".
Event or Problem Description
A (b)(6) male patient had a pedicle screw system placed at l5/s1 on (b)(6) 2015.Approximately 10 months after surgery, radiograph images indicated one of the pedicle screws had fractured.No patient injury has been reported.

• Brand Name: NUVASIVE PRECEPT SPINAL SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 5946992
• Report Number: 2031966-2016-00068
• Device Sequence Number: 16544992
• Product Code: NKB
• UDI-Device Identifier: 00887517387554
• UDI-Public: 00887517387554
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 8896550
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2016
• Initial Report FDA Received Date: 09/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR