MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE OCT SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	8970000
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of explanted components as well as associated instrumentation noted that the lock screws exhibited markings consistent with cross-threading, although the screws remained functional.Evaluation of instrumentation noted no failure to tighten to specified torque level.The event appears to be related to incorrect engagement of lock screws and polyaxial screws; the cause of this is unclear.One polyaxial screw separated from bone, suggesting an impact may have occurred, although that has not been confirmed.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,.".
Event or Problem Description
On (b)(6) 2017 a six-level posterior cervical fixation was performed.On (b)(6) 2017 it was reported a revision surgery was performed due to loosening of multiple lock screws.No injury was reported.

• Brand Name: NUVASIVE OCT SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6452386
• Report Number: 2031966-2017-00037
• Device Sequence Number: 875049
• Product Code: MNI
• UDI-Device Identifier: 00887517397133
• UDI-Public: 00887517397133
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150474
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/02/2017

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: 8970000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1