MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE POLYAXIAL SPINAL SCREWS; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	8800000
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No radiographs were received to confirm the event.No product has been returned for investigation.No root cause can be determined 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: ".Confirm heights of screws match with patient's lordosis when securing lock screws.Failure to verify screw height following insertion may result in inadequate rod normalization." ".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." device not returned.
Event or Problem Description
On (b)(6) 2017, a revision surgery occurred due to back out of the s1 screw on the left side.The s1 screw was left in situ and the left side of the construct was extended to the s2ai level.No patient injury was reported.

• Brand Name: NUVASIVE POLYAXIAL SPINAL SCREWS
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6686376
• Report Number: 2031966-2017-00082
• Device Sequence Number: 150379
• Product Code: NKB
• UDI-Device Identifier: 00887517344076
• UDI-Public: 00887517344076
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/05/2017

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: Physician
• Device Model Number: 8800000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2017
• Initial Report FDA Received Date: 07/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1