MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RISE-L; RISE-L SPACER, 18X45MM, 7-14MM, 3-15°

Model Number	193.503
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	01/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One rise-l spacer was returned for evaluation due to unintended disassembly of the device intraoperatively.The spacer was used in a multi-level atp case from l1-l5 (dos: (b)(6) 2024), and was reported to have broken after the surgeon collapsed and removed the implant from the disc space to retrieve a piece of gauze that was left in the patient.Another rise-l spacer was used to replace the disassembled cage, and the case was completed without any further incidents or adverse effects to the patient.Initial observation of the rise-l spacer showed that the retaining c-ring was no longer attached to the drive screw, allowing it to migrate out of the implant when the spacer is fully collapsed.As such, the implant fails to meet functional requirements specified by the part drawing.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that during a surgery a rise-l spacer was broken during a procedure and had to be retrieved from the patient.This event occurred in japan.

• Brand Name: RISE-L
• Common Device Name: RISE-L SPACER, 18X45MM, 7-14MM, 3-15°
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• 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: 18888778
• Report Number: 3004142400-2024-00050
• Device Sequence Number: 3089578
• Product Code: MAX
• UDI-Device Identifier: 00889095308129
• UDI-Public: 00889095308129
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K113447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2024

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: 193.503
• Device Lot Number: WTB130YD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2023
• 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: Other
• Patient Sex: Unknown
• Patient Race: Asian