MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE® MODULUS XLIF INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	1775850
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023 a patient underwent a extreme lateral interbody fusion procedure on unknown level of the spine.During the procedure the distal tip of inserter fractured off into the cage and was left in the patient as it was determined intraoperatively that it could cause more trauma to the patient to explant the cage opposed to leaving it cold welded in the engaged screw.No patient injury or consequence was reported.
Additional Manufacturer Narrative
The device was received by nuvasive on july 26, 2023 and the complaint was confirmed.Manufacturing review identified lot ms5491r was released to the field january 2019.Servicing examination of returned inserter found the distal tip fractured off and was likely the result of excessive use fatigue and or off angled excessive force during use indicating wear fatigue as the root cause.The fractured tip per surgeons prerogative was left in-situ fixed in the interbody attachment feature, the stainless steel materials that were unretrieved in this event can be considered to exert very low toxicity potential and to pose negligible risk to the patient.Label review : "potential adverse events and complications as with any major surgical procedures, there are risks involved in spinal/orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries"."warnings, cautions and precautions the subject device is intended for use only as indicated.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"."based on fatigue testing results, when using the modulus interbody system, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact on the performance of this system"."care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient".

• Brand Name: NUVASIVE® MODULUS XLIF INTERBODY SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 17446007
• Report Number: 2031966-2023-00156
• Device Sequence Number: 14077140
• Product Code: MAX
• UDI-Device Identifier: 00887517913425
• UDI-Public: 887517913425
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K172123
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 07/05/2023

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: 1775850
• Device Lot Number: MS5491R
• 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: 07/05/2023
• Initial Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2019
• 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: Prefer Not To Disclose