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

Model Number	11101255
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
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
It was reported that dr (b)(6) did a revision surgery and used 10 reline -o connectors.A few days later, the patient heard a "pop" and upon an xray, it was determined the rod pulled out of the connector.We had to do a revision surgery to replace all of the connectors.

• 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: 23816009
• Report Number: 2031966-2025-00165
• Device Sequence Number: 18479221
• Product Code: MNI
• UDI-Device Identifier: 00887517596147
• UDI-Public: 887517596147
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 12/16/2025

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: 11101255
• 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: 11/10/2025
• Initial Report FDA Received Date: 12/16/2025
• 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: Required Intervention
• Patient Sex: Unknown