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

Model Number	13600000
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/04/2026
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 6.0 reline set screw failed while being tightened during an ais scoli fusion case with dr.Jon oda.Dr.Oda was provisionally tightening the set screw into a hook at the top of the construct when he indicated it felt strange.Upon removal a long thread of metal had sheared off but was still attached to the set screw.This extended surgery by approx.30 minutes as the doctor attempted to reduce the rod to the hook again and insert new set screw.

• 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: 24462118
• Report Number: 2031966-2026-00037
• Device Sequence Number: 18492616
• Product Code: OSH
• UDI-Device Identifier: 00887517551719
• UDI-Public: 00887517551719
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/26/2026

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: 13600000
• 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: 02/05/2026
• Initial Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown