MAUDE Adverse Event Report: NUVASIVE, INC. MAXCESS; STIMULATOR, NERVE

Model Number	3240309
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Kidney injury (4882)
Date of Event	06/12/2026
Type of Reportable Event	Serious Injury
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
It was reported that the surgeon was doing a revision surgery where the original surgery was completed in 2014 using another company's products (medacta) the surgeon did an xlif using the nuvasive maxcess 4 retractor and inserter modulus cages with single hole plates attached at those two levels.He then proceeded to move the retractor up to l1/2 and, whilst positioning the retractor, he made a comment about the patient "hosing blood".He packed the wound using various hemostatic agents and gauze on and off for approximately 30 minutes before asking if a vascular surgeon could be contacted as the patient continued to bleed.At this point dr.Rosenberg told me that he was going to abort any instrumentation at l1/2.The anesthetist approximated that the blood loss was 100-200ml.The vascular surgeon scrubbed in and after approximately an hour of trying to identify and stop the bleeding he decided that patient needed to be moved to a supine position so that he could get better visualisation.While in this position the vascular surgeon identified that there was a kidney involved and that there was gauze in/around one of the patient's kidney's.He asked for a general surgeon to be called and from my understanding this was done to try and save the patient's kidney.The general surgeon scrubbed in and assisted in identifying what was going on and to try and rectify it.This was an unexpected bad outcome for the patient who had an extended stay in hospital and delay for part two of planned surgery.

• Brand Name: MAXCESS
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; 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: 25669246
• Report Number: 2031966-2026-00086
• Device Sequence Number: 18756592
• Product Code: ETN
• UDI-Device Identifier: 00887517196699
• UDI-Public: 887517196699
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K112709
• 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
• Report Date (Section B): 06/30/2026

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: 3240309
• 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: 06/17/2026
• Initial Report FDA Received Date: 06/30/2026
• 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 Age: 57 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White