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

Model Number	8970000
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the ex-planted devices found no evidence that final torque off was achieved.The root cause of the lock screw back out is insufficient torque which may be the result of failure to conduct final torque off procedure or a malfunctioning torque device.The torque device was unavailable for evaluation.No further testing can be completed at this time.Manufacturing review: review of the device history records of all devices notes no material non-conformance's, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to this mode of failure.Parts met acceptance criteria upon release.Labeling review: ".All implants should be used only with the appropriately designated instrument (reference surgical technique)." ".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." ".Contraindications include but are not limited to: 1.Infection, local to the operative site.2.Signs of local inflammation.3.Patients with known sensitivity to the materials implanted.4.Patients who are unwilling to restrict activities or follow medical advice.".
Event or Problem Description
On (b)(6) 2018 a patient underwent a posterior fixation procedure at c2-c6 without any reported issues.On a later date post-operative radiographs revealed three backed out lock screws at c2-c4 levels.On (b)(6) 2018 a revision procedure took place to remove and replace the three lock screws without a reported issue.

• Brand Name: NUVASIVE VUEPOINT OCT SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 8120566
• Report Number: 2031966-2018-00171
• Device Sequence Number: 1682652
• Product Code: KWP
• UDI-Device Identifier: 00887517397133
• UDI-Public: 00887517397133
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K093319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2018

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: Health Professional
• Device Model Number: 8970000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 11/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR