MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. AUTOBAHN EVO; AUTOBAHN EVO LOCKING SCREW, 5X75MM, TI

Model Number	1257.8375
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The part has been received but not yet reviewed.The observed overall risk is low, which does not exceed the observed anticipated risk level; therefore, the overall risk of the system has been maintained.The exact cause of the failure cannot be determined at this time.
Event or Problem Description
It was reported that a revision was needed to replace an autobahn evo locking screw that backed out post operatively.
Event or Problem Description
It was reported that a revision was needed to replace an autobahn evo locking screw that backed out post operatively.
Additional Manufacturer Narrative
The device was available for evaluation.The overall observed risk level is medium.This evaluation determined that the reported failure was within expected risk; therefore, no further action will be taken at this time.No determinations could be made as to the cause of the reported issue.

• Brand Name: AUTOBAHN EVO
• Common Device Name: AUTOBAHN EVO LOCKING SCREW, 5X75MM, TI
• 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: 21413372
• Report Number: 3004142400-2025-00031
• Device Sequence Number: 18221994
• Product Code: HSB
• UDI-Device Identifier: 00193982485993
• UDI-Public: 00193982485993
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K220659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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: 1257.8375
• Device Lot Number: BAC137MC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2024
• 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 Age: 81 YR
• Patient Sex: Male