MAUDE Adverse Event Report: NUVASIVE, INC. RELINE; BONE-SCREW INTERNAL SPINAL FIXATION SYSTEM CONNECTOR

Model Number	11104055
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
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 the left and right spinal rods were set in (b)(6) 2021 broke between l1/l2 vertebrae.Supplemental rods were installed on both sides for reinforcement, but the rods later came loose from the left and right rods from the connector on the cranial side.The surgeon performed surgery again on (b)(6) 2025, to replace spinal screws and spinal rods.We do not receive any other adverse patient consequences reported.

• Brand Name: RELINE
• Common Device Name: BONE-SCREW INTERNAL SPINAL FIXATION SYSTEM CONNECTOR
• 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: 24057185
• Report Number: 2031966-2026-00011
• Device Sequence Number: 9856023
• Product Code: KWP
• UDI-Device Identifier: 00887517596246
• UDI-Public: 887517596246
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• 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): 01/13/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11104055
• Device Lot Number: IA7515 & IA7704
• 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: 12/18/2025
• Initial Report FDA Received Date: 01/13/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male