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

Model Number	7070000
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation, a review of mri images provided confirm the alleged event.As per reporter a new larger diameter screw was placed at the s1 level and the construct was locked down.Labeling review: ".Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)." ".Final-tighten all lock screws with the counter-torque and torque t-handle.Do not final-tighten through other instruments in the set, as the rod may not be able to normalize to the tulip.Ensure there is enough rod overhang when final tightening, and do not lock down on the conical portion of the rod.Failure to do so may lead to improper lock down of the construct.It may be necessary for the surgeon to add length to the rod, depending upon patient anatomy and desired lordosis." no product has been returned.
Event or Problem Description
On (b)(6) 2017 patient underwent a posterior lumbar interbody fusion procedure on l4-s1 levels.On (b)(6) 2018 a revision procedure was performed to due to loosen bilateral screws at the s1 level.The patient is reported to be doing well post revision procedure.

• 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: 7436570
• Report Number: 2031966-2018-00039
• Device Sequence Number: 19106139
• 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
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/17/2018

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: 03/26/2018
• Initial Report FDA Received Date: 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR