ACF 396.420Recalls & reported problems
Synthes GmbH · ACF TRIAL SPACER/LORDOTIC 10MM · Class 1
Data updated Oct 16, 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 10705034777702), received between Apr 17, 2020 and Jul 5, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Compatibility Problem1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 5, 2024Mechanical Problem; Compatibility Problem; Mechanical Problem; Compatibility Problem
IT WAS REPORTED THAT AFTER AN ANTERIOR CERVICAL FUSION PROCEDURE ON (B)(6) 2024, THE PRODUCTS¿ HANDLES WERE LOOSE, AND THE PINS TO HOLD THE HANDLES WERE LOOSE. THIS WAS OBSERVED POSTOPERATIVELY UPON INSPECTION IN THE STERILE PROCESSING DEPARTMENT. ANOTHER PRODUCT WAS USED IN SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE ACF TRIAL SPACER/LORDOTIC 10MM. THIS IS REPORT 1 OF 3 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19681801 ↗MalfunctionApr 17, 2020Break; Break
IT WAS REPORTED THAT ON MARCH 24, 2020 THE ACF TRIAL SPACER LORDOTIC WAS FOUND TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) ACF TRIAL SPACER/LORDOTIC 10MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9974176 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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