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

Model Number	8457540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Even though no product was returned for evaluation a photographic review of the product confirms the alleged event.Labeling review: 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)." warnings, cautions and precautions: ".These devices can break when subjected to the increased load associated with delayed union or nonunion.Internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs.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.The patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed." no product has been returned.
Event or Problem Description
On (b)(6) 2017, patient underwent a spinal procedure from l3 to s1 levels.Patient was experiencing pain and a scan showed bilateral screw fractures at the s1 level.On (b)(6) 2018 a revision procedure was performed and screws were replaced.The patient is reported to be doing fine post procedure.

• Brand Name: NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 7659878
• Report Number: 2031966-2018-00114
• Device Sequence Number: 19490458
• Product Code: NKB
• UDI-Device Identifier: 00887517272331
• UDI-Public: 00887517272331
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K092287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/03/2018

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: 8457540
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR