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

Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation as product remains in-situ.A radiograph was provided and alleged event was confirmed.It is unknown if patient followed post-operative restrictions or suffered a fall.Patient's bone quality is unknown.No root cause can be confirmed at this time.Labeling review: ".Potential adverse events and complications: 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." ".Warnings, cautions and precautions: if healing is delayed, or does not occur, the implant may eventually loosen, bend, or break." ¿.Patient education: the patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components." ¿.Post-operative warnings: damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration.".
Event or Problem Description
A patient underwent a cervical spinal fusion procedure at c4-c7 levels on (b)(6) 2020.Two weeks postoperatively, radiographs revealed a screw had backed-out of the plate.No revision procedure has been scheduled at this time.

• Brand Name: NUVASIVE HELIX REVOLUTION ACP SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 9931052
• Report Number: 2031966-2020-00074
• Device Sequence Number: 2817796
• Product Code: KWQ
• UDI-Device Identifier: 00887517135599
• UDI-Public: 887517135599
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K093804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2020

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1