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

Model Number	7734117
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned for investigation nor radiographs were provided to confirm the event.Potential adverse events and complications "as with any major surgical procedures, there are risks involved in orthopedic surgery.Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)." no product returned.
Event or Problem Description
On (b)(6) 2017 patient underwent a revision surgery due to helix screw backout.Patient was reported to have no issues post surgery.

• Brand Name: NUVASIVE HELIX 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: 6748522
• Report Number: 2031966-2017-00096
• Device Sequence Number: 19216989
• Product Code: KWQ
• UDI-Device Identifier: 00887517091758
• UDI-Public: 00887517091758
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K083341
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/27/2017

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: No Information
• Device Model Number: 7734117
• Device Lot Number: M28205
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 07/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1