MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE RELINE MAS SYSTEM; STIMULATOR, NERVE

Model Number	10000425
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned.Evaluation of the device was able to confirm the reported tip fracture and identified the cause as excessive force.Based on the information obtained, the root cause of the reported event was determined to be excessive force placed on the device as a result of the patient's extremely hard bone.Labeling review: "warnings, cautions and precautions: the implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient." "care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." " the instruments should be treated as any precision instrument and should be carefully placed on trays, cleaned after each use, and stored, according to generally accepted hospital methods and practices.The instruments should be carefully examined prior to use for functionality, excessive wear, or damage.A damaged instrument should not be used as this may increase the risk of malfunction and potential patient injury." " the physical characteristics required for many instruments do not permit them to be manufactured from implantable materials.If any broken fragments of instruments remain in the body of a patient, they could cause allergic reactions or infections.If an instrument breaks in surgery and fragments go into the patient, these pieces should be removed prior to closure and should not be implanted.".
Event or Problem Description
It was reported that during a procedure while the surgeon was tapping, the distal tip of the tap fractured.The fractured portion was unable to be retrieved and was left in-situ.No further patient impact was reported.No additional information was provided.

• Brand Name: NUVASIVE RELINE MAS SYSTEM
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: patrick yrigoyen ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 19244070
• Report Number: 2031966-2024-00133
• Device Sequence Number: 7495151
• Product Code: ETN
• UDI-Device Identifier: 00887517511225
• UDI-Public: 887517511225
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K112709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/03/2024

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: Health Professional
• Device Model Number: 10000425
• Device Lot Number: NG92335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown