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

Model Number	7140210
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that both xlif decade plates were implanted at l3-4 and l2-3 levels as part of xlif procedure.After repositioning patient and acquiring intraoperative ct, metal artifacts were observed in in the area of each plate.Upon further examination on fluoroscopy, it was determined metal debris was left behind from the xlif.Patient was re-exposed via lateral approach, and the metal debris was retrieved and both found to be a broken portion of the plate lock screw.
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: XLIF DECADE PLATE
• 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: 24987675
• Report Number: 2031966-2026-00060
• Device Sequence Number: 15822739
• Product Code: KWQ
• UDI-Device Identifier: 00887517316578
• UDI-Public: 00887517316578
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121815
• 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): 04/24/2026

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: 7140210
• 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: 04/24/2026
• Initial Report FDA Received Date: 04/24/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown