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

Model Number	7803115
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is no known malfunction of the nuvasive interbody implants nor any information suggesting difficulty in initial placement of the construct.Review of radiographs as well as the time period between index and revision surgeries suggest the possibility of non-union as a contributor to the event.It is unknown if patient complied with post-operative instructions.Review of the device history records for the explanted devices notes no material nonconformances, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions related to the plate or screws.The implants met acceptance criteria upon release.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.If healing is delayed or does not occur, the implant may eventually loosen, bend or break.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
In (b)(6) 2014 a (b)(6) female underwent a three level acp surgery at c3-c6.No trauma or injury was confirmed.Patient did not complain of pain but radiograph confirmed that the screw had backed out.Revision surgery took place on (b)(6) 2016.

• 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: 5572039
• Report Number: 2031966-2016-00031
• Device Sequence Number: 517217
• Product Code: KWQ
• UDI-Device Identifier: 00887517138934
• UDI-Public: 00887517138934
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K093804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/11/2016

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: 7803115
• Device Lot Number: BB4698
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2016
• Initial Report FDA Received Date: 04/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR