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

Model Number	13550000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/29/2026
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 the patient had index l4-s1 mis tlif (b)(6) 2026.Two weeks post-op, patient reported he ¿bent over and heard a pop¿.Upon x-ray examination, the reline mas modular screw head disassociated from the reline mas modular screw shank.The contralateral set screw at l4 was also loose.Screw replacement revision took place on.

• 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: 24447093
• Report Number: 2031966-2026-00035
• Device Sequence Number: 18735118
• Product Code: KWQ
• UDI-Device Identifier: 00887517551702
• UDI-Public: 00887517551702
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• 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): 02/25/2026

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: 13550000
• Device Lot Number: N461538
• 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: 01/30/2026
• Initial Report FDA Received Date: 02/25/2026
• 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