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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Threads for inserter broke off.
Additional Manufacturer Narrative
The device was not received by nuvasive as it currently remains in-situ although the complaint was confirmed via provided lateral radiograph.Examination of similar complaint records noted that fracturing is consistent with excessive force.A design review determined that excessive angulation for this standard driver was identified at 15 degrees or more but no surgical approach information was provided.No lot code information was provided so a complete manufacturing review could not be completed.Although review of ncmr records and similar events notes no non-conformances with respect to material type, treatments or dimensions that may have caused or contributed to this mode of failure.The root cause of the reported unretrieved tip fracture is unknown but is likely considered to be the result of field damage and a combination of off angled force and wear fatigue.The fractured tip, per surgeon¿s prerogative, was left in-situ fixed in the implant, 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.No additional investigation can be completed.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: geoffry gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 17700992
• Report Number: 2031966-2023-00187
• Device Sequence Number: 6745888
• Product Code: MAX
• UDI-Device Identifier: 00887517913425
• UDI-Public: 887517913425
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/07/2023

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
• 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: 09/07/2023
• Initial Report FDA Received Date: 09/07/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female