MAUDE Adverse Event Report: NUVASIVE, INC NUVASIVE SPHERX SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	7782004
Medical Device Problem Codes	Detachment Of Device Component (1104); Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A radiograph was received which confirmed the event.No product has returned for evaluation therefore root cause cannot be identified.Labeling review potential adverse events and complications "potential risk identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s), loss of fixation." patient education: "preoperative instructions to the patient are essential.The patient should be made aware of the limitations of the implant and potential risks of the surgery.The patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components.The patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed.".
Event or Problem Description
On (b)(6) 2017, a patient underwent a lumbar fusion procedure at l5.Postoperatively, it was reported a tulip, rod and lock screw disengaged from the shank.Revision surgery was performed on (b)(6) 2017 no patient injury reported.

• Brand Name: NUVASIVE SPHERX SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): NUVASIVE, INC; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6637395
• Report Number: 2031966-2017-00066
• Device Sequence Number: 614009
• Product Code: NKB
• UDI-Device Identifier: 00887517121738
• UDI-Public: 00887517121738
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K090981
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/13/2017

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: 7782004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2017
• Initial Report FDA Received Date: 06/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1