MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	7070000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation as product remains in-situ.A review of the x-ray picture confirms the alleged event.No revision procedure will be performed 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)." ".These devices can break when subjected to the increased load associated with delayed union or nonunion." ".Patient education: 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." post-operative warnings ".Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration as well as to other complications." product remains in-situ.
Event or Problem Description
A patient underwent index surgery on (b)(6) 2017 for a single level cortical screw fusion from l3 to l4 level.On (b)(6) 2018 a revision procedure was performed to extend the fusion of l3-s1 levels.During a routine follow up it as discovered that a screw on the right side of the l4 level had fractured.As per reporter, patient is asymptomatic and no revision procedure will be performed at this time.

• Brand Name: NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 7492670
• Report Number: 2031966-2018-00053
• Device Sequence Number: 13501321
• Product Code: NKB
• UDI-Device Identifier: 00887517204028
• UDI-Public: 00887517204028
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K102514
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/07/2018

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: 7070000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR