AUTOBAHN 1257.8345Recalls & reported problems
Globus Medical, Inc. · AUTOBAHN EVO Locking Screw, 5x45mm, Ti · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00193982485870), received between May 26, 2026 and Jun 16, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Human-Device Interface Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 16, 2026Fracture
IT WAS REPORTED THAT A 90MM LAG SCREW BROKEN AT BASE OR THREADS. THE OLDER PATIENT ARRIVED TO HOSPITAL WITH NONUNION AND BROKEN LAG SCREW ON (B)(6) 2026, REQUIRING A REVISION SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25522787 ↗MalfunctionMay 26, 2026Human-Device Interface Problem
IT WAS REPORTED THAT THE SURGEON INSERTED EVO ANTEGRADE NAIL ON (B)(6) 2026 AND HAD TO REVISE ON (B)(6) 2026 DUE TO DISTAL SCREW BREAKAGE AND SCREW BACK OUT. THE MOST PROXIMAL DISTAL SCREW BROKE AND THE MOST DISTAL SCREW BACKED OUT OF NAIL. THE PATIENT HAD A "KNEE BUCKLING" EPISODE POST OPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25284103 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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