MAUDE Adverse Event Report: NUVASIVE, INC. RELINE; SPINAL BONE SCREW, NON-BIOABSORBABLE

Model Number	13016540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been received for evaluation.The root cause cannot be determined at this time.A supplemental report will be submitted upon receipt of additional information.
Event or Problem Description
It was reported that a patient had two 6.5x40 mm screws break in her s1 vertebra.She reports no injuries, sudden movements, or high-impact events.The patient underwent her first surgery approximately one year ago.The initial procedure involved two levels of repair (l4-s1).Following this, she underwent a second surgery yesterday after the two s1 screws were found to be broken.During the second surgery, possible pseudoarthrosis was observed on the left side, while the right side was well-adhered.Metallosis was also observed on both sides.This event occurred in spain.
Additional Manufacturer Narrative
The complaint file was evaluated and it was determined that the report relates to a nuvasive reline-o screw, 6.5x40mm 2s polyaxial.The report indicates that the patient underwent an initial procedure around a year ago that involved two levels of repair (l4-s1).A second operation was conducted after the s1 screws were found to be broken.There was no patient injury associated with this reported event.Specified regulatory reporting has been completed.The product was returned and the complaint was confirmed.The root cause is unknown however it was reported as being due to normal wear and tear over time, so it could have been due to improper loading that exceeds the fatigue strength of the implant.Also, upon review of the x-ray imaging, it appears to show no interbody stabilization in the l5/s1 motion segment so there may have been unexpected loading in that area.Causes of and contributors to the event type are believed to be known.Labeling, manufacturing, risk and trend 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 a patient had two 6.5x40 mm screws break in her s1 vertebra.She reports no injuries, sudden movements, or high-impact events.The patient underwent her first surgery approximately one year ago.The initial procedure involved two levels of repair (l4-s1).Following this, she underwent a second surgery yesterday after the two s1 screws were found to be broken.During the second surgery, possible pseudoarthrosis was observed on the left side, while the right side was well-adhered.Metallosis was also observed on both sides.This event occurred in spain.

• Brand Name: RELINE
• Common Device Name: SPINAL BONE SCREW, NON-BIOABSORBABLE
• 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: 24315374
• Report Number: 2031966-2026-00022
• Device Sequence Number: 4837711
• Product Code: MNH
• UDI-Device Identifier: 00887517537201
• UDI-Public: 00887517537201
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K143684
• 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): 03/26/2026

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: 13016540
• Device Lot Number: N363029
• Was Device Available for Evaluation?: Yes
• 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: 01/27/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Weight: 50 KG