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ACF 396.416Recalls & reported problems

Synthes GmbH · ACF TRIAL SPACER/LORDOTIC 6MM · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034777665), received between Oct 14, 2019 and Oct 14, 2019 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 14, 2019Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2019, AN ANTERIOR CERVICAL FUSION TRIAL SPACER WAS NOTED TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICES AT (B)(6). THERE WAS NO PATIENT INVOLVEMENT THIS IS REPORT 1 FOR 1 (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9186409 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.