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

Model Number	8448590
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During surgery the tulip head of one iliac screw disengaged from the tulip and the thread in the shank was stripped.Fixation was applied from the upper thoracic spine to the iliac spine.The surgeon elected to leave the screw in place due to the length of the construct and point at which the component separation occurred.The surgeon will continue to monitor the patient.No further investigation can be completed at this time.No revision surgery is scheduled.The root cause of this reported event has not been determined.Review of labeling notes: 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 remains in-situ.
Event or Problem Description
On 12/12/2016 it was reported that during a thoracic lumbar surgery on (b)(6) 2016, the tulip head of one iliac screw disengaged and the thread in the shank was stripped.The screw was left in the patient and no patient injury was reported.The surgeon has elected to monitor the patient.No revision surgery is scheduled at this time.

• 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: 6226208
• Report Number: 2031966-2016-00093
• Device Sequence Number: 16351562
• Product Code: NKB
• UDI-Device Identifier: 00887517256492
• UDI-Public: 00887517256492
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K092287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/05/2017

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: 8448590
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2016
• Initial Report FDA Received Date: 01/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR