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

Model Number	16387555P
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a postop routine patient control, a failure of the initial construct was identified by the surgeons oa.Andreas flossmann and oa.Waclav brunner-urbanski.Right sided road has completely dislocated from the tulips after 3 months, but set screws are still in place.No interoperative problems have been occurring on the primary treatment.No issues have been documented.Pile driver has been used for all mono screws to secure a proper fit of the rod/screw/set screw construct.
Additional Manufacturer Narrative
The device is unavailable for evaluation as it remains in situ.The root cause cannot be determined at this time.A supplemental report will be submitted upon receipt of additional information.

• 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 avenu; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenu; audubon, PA 19403 ; 6109301800
• MDR Report Key: 25510710
• Report Number: 2031966-2026-00080
• Device Sequence Number: 18779575
• Product Code: NKB
• UDI-Device Identifier: 00887517043931
• UDI-Public: 887517043931
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K180498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 06/15/2026

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: 16387555P
• Device Lot Number: ML7534
• 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: 06/01/2026
• Initial Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 39 YR
• Patient Sex: Male
• Patient Weight: 79 KG