MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	8439560
Medical Device Problem Codes	Misconnection (1399); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/08/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product returned left in-situ.The degree of spinal instability is unknown.Patient's bone quality was unknown.No revision is planned at this time; the patient will continue to be monitored.The root cause of this reported event has not been determined.Labeling review: 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; nonunion or delayed union; fracture of the vertebra; neurological, vascular or visceral injury; metal sensitivity or allergic reaction to a foreign body.Device has not been returned.
Event or Problem Description
On (b)(6) 2015 a female patients post-operative radiolographs showed the left-side iliac screw components had separated.No additional information has been provided.No injury has been reported.

• Brand Name: NUVASIVE SPHERX II - PEDICLE SCREW 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: 5352213
• Report Number: 2031966-2015-00089
• Device Sequence Number: 161381
• Product Code: NKB
• UDI-Device Identifier: 00887517252654
• UDI-Public: 00887517252654
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K092287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Report Date (Section B): 01/06/2015

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: 8439560
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1