ACF 396.989Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034778198), received between Apr 17, 2019 and Jan 21, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (4 reports).

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

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT SPINAL FUSION ON AN UNKNOWN DATE IN (B)(6) 2025. THE INNER SHAFT BROKE. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21197798 ↗
• MalfunctionFeb 7, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS FURTHER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT OR ANY RELATED OUTCOMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18659864 ↗
• MalfunctionJun 8, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN KUWAIT AS FOLLOWS: IT WAS REPORTED THAT CERVIOS HOLDER AFTER LOADING THE CAGE IT'S STUCK TO THE CAGE AND NOT OPENED (THE ITEM HAS BEEN USED FOR THE FIRST TIME). THIS REPORT IS FOR ONE (1) UNK - CAGE/SPACERS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17088319 ↗
• MalfunctionMay 12, 2020Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT DURING EVALUATION AT LOANER DEPARTMENT ON (B)(6) 2020, THE INNER SHAFT OF THE ACF TRIAL SPACER HANDLE WAS NOTICED TO HAVE STUCK. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS REPORT INVOLVES ONE (1) ACF TRIAL SPACER HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10047770 ↗
• MalfunctionJul 9, 2019Mechanical Jam; Mechanical Jam

  IT WAS DISCOVERED ON ONE DRIVER DURING THE BEGINNING OF SURGERY THAT THE SET WAS SWITCHED OUT FOR ANOTHER. THIS WAS DUE TO THE OTHER DRIVER THAT WAS IN BETTER CONDITION. IT WAS THEN DISCOVERED THAT ALL FOUR DEVICES NEEDED TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8772499 ↗
• MalfunctionJul 9, 2019Mechanical Jam; Mechanical Jam

  IT WAS DISCOVERED ON ONE DRIVER DURING THE BEGINNING OF SURGERY THAT THE SET WAS SWITCHED OUT FOR ANOTHER. THIS WAS DUE TO THE OTHER DRIVER THAT WAS IN BETTER CONDITION. IT WAS THEN DISCOVERED THAT ALL FOUR DEVICES NEEDED TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8772326 ↗
• MalfunctionJul 9, 2019Mechanical Jam; Mechanical Jam

  IT WAS DISCOVERED ON ONE DRIVER DURING THE BEGINNING OF SURGERY THAT THE SET WAS SWITCHED OUT FOR ANOTHER. THIS WAS DUE TO THE OTHER DRIVER THAT WAS IN BETTER CONDITION. IT WAS THEN DISCOVERED THAT ALL FOUR DEVICES NEEDED TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8772316 ↗
• MalfunctionJul 9, 2019Mechanical Jam; Mechanical Jam

  IT WAS DISCOVERED ON ONE DRIVER DURING THE BEGINNING OF SURGERY THAT THE SET WAS SWITCHED OUT FOR ANOTHER. THIS WAS DUE TO THE OTHER DRIVER THAT WAS IN BETTER CONDITION. IT WAS THEN DISCOVERED THAT ALL FOUR DEVICES NEEDED TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8772311 ↗
• MalfunctionApr 17, 2019Break; Break

  4/22/2019: UPDATE: CONCOMITANT PART/LOT WAS DISCOVERED DURING (IR) INVESTIGATION REPORT. CONCOMITANT DEVICE: PRODUCT CODE: 396.922 LOT #: 6554757 QTY: 1 WAS RETURNED AS A CONCOMITANT DEVICE WITHOUT AN ALLEGED COMPLAINT CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8523687 ↗