MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. AUTOBAHN; ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, NON-STERILE

Model Number	1257.8370
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient presented with comorbidities, these could have potentially affected the screw back-out due to obesity putting additional stress and force on the implant and the other comorbidities affecting the quality of screw purchase in bone.The complaint was received with no lot number or physical part, so the dhr and ncmr records could not be reviewed.However, x-rays were provided from the end of the original surgery, follow-up visit, and the revision operation, which confirms the failure mode.In the original surgery x-ray, it is confirmed that the screws were fully inserted and that the screw heads were contacting bone.In the first screw back-out x-ray, it is confirmed that the most distal 80mm screw was backed off of bone.Additionally, it is confirmed in the last x-ray that the 70mm screw was slightly backed off of bone and seen during the revision operation, requiring removal.Based on the risk analysis, it is possible that the screw backed out due to poor screw purchase, poor bone quality, and/or abnormal cyclic loading.Additionally, patient comorbidities may have contributed to the back-out occurring.However, based on the observations and the information provided, it is not possible to definitively determine the cause of failure.This evaluation determined that this failure did not exceed expected risk; therefore, no further actions will be taken at this time.If the complaint parts are received in the future, the investigation will be reopened at that time.
Event or Problem Description
It was reported that the patient's original surgery date was (b)(6) 2025.The patient had a 10x240 sfx retrograde nail inserted as well as a smith & nephew distal femur plate.When patient followed up in clinic on (b)(6) 2026, imagine showed that the 80mm screw in the most distal medial to lateral hole was backed out.The fracture is healed but surgeon removed the screw today on (b)(6) 2026.During the revision, it was also noticed that the 70mm screw in the 2nd most proximal distal screw was also backed out so he removed that as well.

• Brand Name: AUTOBAHN
• Common Device Name: ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, NON-STERILE
• 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: 24817406
• Report Number: 3004142400-2026-00062
• Device Sequence Number: 6011760
• Product Code: HSB
• UDI-Device Identifier: 00193982485979
• UDI-Public: 00193982485979
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K220659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/08/2026

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: 1257.8370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 129 KG
• Patient Race: White