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

Model Number	7906120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No radiographs or photos confirming event have been received.The device was discarded at the hospital.Review of implanted components suggests that the construct may have been intended to enhance stability of the cervical spine; no interbody devices were implanted.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, non-union or delayed union." "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 underwent occipitocervical decompression and fusion surgery in (b)(6) 2012.Around 4 years postoperative, the rods between occ plate and c2 screws had fractured.They were removed and replaced with new rods.

• Brand Name: VUEPOINT OCT SYSTEM
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS.
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6082064
• Report Number: 2031966-2016-00079
• Device Sequence Number: 271074
• Product Code: KWP
• UDI-Device Identifier: 00887517183873
• UDI-Public: 00887517183873
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K093319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/02/2016

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: 7906120
• Device Lot Number: UNKNOWN
• 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: 11/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR