MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RISE EXPANDABLE SPACER; LATERAL INSERTER

Model Number	693.601
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During surgery the patient's retroperitoneum was damaged while being rolled between two instruments.This event occurred in japan. .
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Neither the device or any imaging could be provided for evaluation.No determinations could be made as to the cause of the reported issue.The following sections have been updated: b4, g6, h2, h10 and b4, e1, h2, h6, h10.

• Brand Name: RISE EXPANDABLE SPACER
• Common Device Name: LATERAL INSERTER
• 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: 18837896
• Report Number: 3004142400-2023-00131
• Device Sequence Number: 7246025
• Product Code: LXH
• UDI-Device Identifier: 00889095058468
• UDI-Public: 00889095058468
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: D154976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/29/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 693.601
• Device Lot Number: ENX246AF/ENW347AF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2020
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Race: Asian