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

Model Number	8805540A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924)
Date of Event	06/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned; however, radiographic review confirmed the screw fracture.The fracture has been associated with an impact that may have contributed to the reported event.The cause of the event cannot be conclusively determined at this time.Review of labeling notes: warning and 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." device remains in-situ.
Event or Problem Description
On (b)(6) 2015 a female patient had a pedicle screw system placed at l4-l5.Reportedly the patient sustained a fall and one of the pedicle screws has broken.The surgeon has elected to monitor the patient.No revision surgery is scheduled at this time.

• Brand Name: NUVASIVE POLYAXIAL SPINAL SCREWS
• 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: 5831239
• Report Number: 2031966-2016-00055
• Device Sequence Number: 13616122
• Product Code: NKB
• UDI-Device Identifier: 00887517449764
• UDI-Public: 00887517449764
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K121619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/28/2016

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: 8805540A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1