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

Model Number	7782001
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the provided radiographs confirmed the alleged event examination of the returned ex-planted device identified damage on the initiation of the first thread which is consistent with cross threading.Cross threading was reported as taking place during the index procedure.The reported event and examination confirm that the root cause of the reported event was the result on an unintended installation error.No additional investigation is required.Labeling review: "rod insertion with the rod fully seated in the screw heads, insert lock screws using the lock screw starter.If required, aligning the timing marks on the lock screw and the screw tulip prior to insertion will position the mating threads in their proper orientation to start the lock screw more easily.Alternately, to align the implants prior to lock screw insertion, use the lock screw starter guide to capture the screw head, followed by introduction of the lock screw starter." "potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component, loss of fixation." "all components should be final tightened per the specifications in the surgical technique.Implants should not be tightened past the locking point, as damage to the implant may occur.".
Event or Problem Description
On (b)(6) 2019 patient underwent a posterior fixation procedure during which a lock screw stripped during placement but was left in place.On (b)(6) 2019 radiographs identified the lock screw backed out and disengaged.On (b)(6) 2019 a revision procedure took place with another surgeon where the backed out lock screw was replaced without a reported issue.No patient injury reported.

• Brand Name: NUVASIVE SPHERX SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 8719354
• Report Number: 2031966-2019-00209
• Device Sequence Number: 2091381
• Product Code: NKB
• UDI-Device Identifier: 00887517121714
• UDI-Public: 887517121714
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/17/2018

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: No Information
• Device Model Number: 7782001
• Device Lot Number: JP7990
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1