MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE STIMULATION/DISSECTION INSTRUMENTS; STIMULATOR, NERVE

Model Number	10000425
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device has been received for evaluation; however, photographs of the device were provided and were able to confirm the reported event as the tip of the device was absent.Additionally, a review of the radiographs provided was also able to confirm the presence of the tip retained in the patient's bone.Finally, information provided by the initial reporter indicated that the patient had very hard sclerotic bone.Based on the information obtained, the root cause of the reported event was likely excessive and/or off-axis force applied to the device during use in combination with the hard/sclerotic patient bone, which likely required more force, making made tap advancement and retrieval more difficult.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." "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." "care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." "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 an extreme lateral interbody fusion with posterior fixation, when tapping the patient's right l2 vertebra, the threaded part of the tap broke off and was retained in the patient's bone.No further patient impact was reported.No additional information was provided.

• Brand Name: NUVASIVE STIMULATION/DISSECTION INSTRUMENTS
• 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: macy stout ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 21548464
• Report Number: 2031966-2025-00036
• Device Sequence Number: 12805616
• Product Code: ETN
• UDI-Device Identifier: 00887517511225
• UDI-Public: 887517511225
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K112709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 03/07/2025

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: NG121762
• Was Device Available for Evaluation?: No
• 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: 02/10/2025
• Initial Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2022
• 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 Age: 57 YR
• Patient Sex: Male
• Patient Weight: 104 KG