MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE RELINE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	10000425
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was returned and examined and the root cause of the failure could not be established.Review of the device history record notes no material non-conformance¿s, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to this mode of failure.Even though root cause could not be confirmed, the fracture of the tap driver was consistent with off-angled and/or excessive force possibly from sclerotic bone.Labeling review: ".Warnings, cautions and precautions: the implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.".
Event or Problem Description
On (b)(6) 2020, patient underwent a two part procedure.First an extreme lateral interbody fusion at l2/3 levels and second, same day a percutaneous posterior fixation.It was reported that a tap driver fractured when a physician was inserting it at the l4 level.The physician tried to remove the piece, however he could not retrieve it.The physician changed the procedure from the percutaneous pedicle screw to an open procedure where the piece was removed.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd.; san diego CA 92121
• MDR Report Key: 10462657
• Report Number: 2031966-2020-00170
• Device Sequence Number: 2344859
• Product Code: NKB
• UDI-Device Identifier: 00887517511225
• UDI-Public: 887517511225
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 10000425
• Device Lot Number: NG79401
• 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: 07/28/2020
• Initial Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1