MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE HELIX REVOLUTION ACP SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	7803117
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The implant was not returned, but radiographs confirmed the screw fracture.The implant remains in-situ and no further investigation can be completed at this time.It is unknown if the patient complied with post-operative instructions; traumatic impacts were reported to not have been a contributor.Root cause has not been determined, no conclusion can be drawn.Review of labeling notes: warning, cautions and precautions "potential risks identified with the use of this device system, which may require additional surgery, include: device component fracture, loss of fixation, fracture of the vertebra, and vascular or visceral injury"."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".Device remains in-situ.
Event or Problem Description
On (b)(6) 215 a male patient underwent an acdf procedure with no complications.At three month follow-up, the construct was noted to be intact.At six month follow-up, radiographs showed a screw had fractured at c7.Surgeon has elected to monitor the patient, no revision surgery is planned at this time.

• Brand Name: NUVASIVE HELIX REVOLUTION ACP SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 5493830
• Report Number: 2031966-2016-00014
• Device Sequence Number: 748549
• Product Code: KWQ
• UDI-Device Identifier: 00887517138958
• UDI-Public: 00887517138958
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Model Number: 7803117
• 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: 03/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1