MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE; ORTHOPAEDIC INORGANIC IMPLANT INSERTER/EXTRACTOR, REUSABLE

Model Number	6904485
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is unavailable for evaluation.The root cause cannot be determined at this time.A supplemental report will be submitted upon receipt of additional information to support this investigation.
Event or Problem Description
L3~l5 xlif this case showed that xlif trial with inserter passed through to the opposite side at intervertebral space of l4/l5 level.The surgeon struck xlif inserter hardly while inserting a trial into the intervertebral space at the l4/l5 level since it was narrow.Bleeding occurred when the surgeon removed the trial with inserter, and the patient¿s blood pressure dropped to the 50s.After compression haemostasias, blood pressure recovered to the 110s within approximately one minute.After confirming successful haemostasias, the surgeon inserted spinal cages into the l3~l5 intervertebral space by xlif, and fixed spine by posterior spinal fixation and closed the surgery.There was no fluctuation in the motor-evoked potential (mep) blood transfusions were also not administered.No other adverse patient consequences were reported.
Additional Manufacturer Narrative
The investigation revealed a complaint reporting that a nuvasive universal inserter, xlif angled passed through the intervertebral space after the surgeon used excessive force to expand the small space.There were blood loss and pressure drop associated with this reported event, but the blood pressure recovered shortly after the drop.The product was not received for manufacturer investigation, and the complaint was non-verifiable.Based on the reported information, a possible root cause of the issue is excessive force and surgeon misuse which can be the consequence of the collapsed intervertebral space.These devices are subjected to handling after distribution into the field, precautions for which are noted in device labeling.Labeling, manufacturing, and risk reviews completed with no deficiencies, discrepancies or adverse trends noted.Complaint monitoring will continue and additional action will be taken in the event that an adverse trend is identified.No additional action is planned at this time.
Event or Problem Description
It was reported that xlif trial with inserter passed through to the opposite side at intervertebral space of l4/l5 level.The surgeon struck xlif inserter hardly while inserting a trial into the intervertebral space at the l4/l5 level since it was narrow.Bleeding occurred when the surgeon removed the trial with inserter, and the patient¿s blood pressure dropped.After compression haemostasias, blood pressure recovered to normal limits within approximately one minute.After confirming successful haemostasias, the surgeon inserted spinal cages into the l3~l5 intervertebral space by xlif, and fixed spine by posterior spinal fixation and closed the surgery.There was no fluctuation in the motor-evoked potential (mep) blood transfusions were also not administered.No other adverse patient consequences reported.

• Brand Name: NUVASIVE
• Common Device Name: ORTHOPAEDIC INORGANIC IMPLANT INSERTER/EXTRACTOR, REUSABLE
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 23917073
• Report Number: 2031966-2025-00170
• Device Sequence Number: 15958500
• Product Code: MAX
• UDI-Device Identifier: 00887517389091
• UDI-Public: 887517389091
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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: 6904485
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female