MAUDE Adverse Event Report: NUVASIVE, INC. RELINE; INTERNAL SPINAL FIXATION PROCEDURE KIT, REUSABLE

Model Number	10000481
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A revision case, surgeon removed a 7.5x55mm reline screw and wanted to replace with an 8.5x55 screw.Tapped with 7.5 tapas the doc always under sizes by 1mm.Advanced the screw about 40/55mm into the pedicle and the screw became so incredibly tight it wouldn¿t move any further.The surgeon had no luck reversing the screw with the reline mas red handle, so attempted a shank driver for more leverage with a t-handle.Driver tip completely broke off inside the shank.We were unable to back the screw completely out.Attempted to put a short rod and set screw inside the tulip to helicopter the screw out, had to snap the towers off.Rod was loose inside the tulip, assuming the driver that broke off was preventing a rigid connection and therefore unable to lock the tulip into a rigid state.We suggested to take the endoscope and look directing into the tulip to see if we could remove the broken driver piece and then retry the rod and helicopter method.The surgeon decided not to.A spine removal set was available for the procedure.
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.

• Brand Name: RELINE
• Common Device Name: INTERNAL SPINAL FIXATION PROCEDURE KIT, REUSABLE
• 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: 24592929
• Report Number: 2031966-2026-00044
• Device Sequence Number: 9495401
• Product Code: LXH
• UDI-Device Identifier: 00887517511782
• UDI-Public: 00887517511782
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 03/13/2026

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: 10000481
• 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: 02/13/2026
• Initial Report FDA Received Date: 03/13/2026
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown