ACIS 03.841.060Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034732404), received between Sep 15, 2020 and Feb 10, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN ACDF C4/5 POSSIBLE REMOVAL OF EXISTING PLATE, THE SURGEON WAS USING ACIS SET TO IMPLANT AN ACIS PRO TI CERVICAL GRAFT. HE INSERTED THE IMPLANT AND UPON REMOVAL OF THE INSERTER REALIZED IT WAS IN TOO FAR. HE LOST MOTORS ON THE PATIENT BELOW THE CHEST. (NO EQUIPMENT BROKE OR MALFUNCTIONED). HE THEN USED A VARIETY OF INSTRUMENTS TO TRY TO REMOVE THE SPACER WHICH HE WAS ABLE TO DO. A NEW GRAFT WAS PLACED AND THE PLATE WAS IMPLANTED WITH SCREWS. ONCE THE CASE WAS COMPLETED NEURO MONITORING SHOWED THAT ONE SIDE OF HER BODY WAS GETTING SOME MOTOR RESPONSE WHILE THE OTHER SIDE WAS NOT. THERE WAS A SURGICAL DELAY WHEN THE GRAFT HAD TO BE REMOVED. THIS REPORT IS FOR ONE (1) INNER SHAFT W/O STOP F/ACIS INSERT DEV. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Paralysis

  MAUDE report 13508353 ↗
• MalfunctionSep 15, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, THE CAGE CANNOT BE TIGHTENED ON THE ACIS INSERTER INSTRUMENT WHICH RESULTED IN A WOBBLE. THE CAGE WAS IMPLANTED EVEN THOUGH THE IMPLANT HOLDER WAS DEFECTIVE. NO REVISION REQUIRED. SURGERY COMPLETED SUCCESSFULLY WITHOUT ANY REPORTED DELAY. NO ADVERSE PATIENT HARM. CONCOMITANT DEVICES REPORTED: INNER SHAFT STD/LRG W/O STOP F/03.841.05 (PART # 03.841.059, LOT # T174656, QUANTITY 1); CAGE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1); ACIS IMPLANT INSERTER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1); INSERTION INSTRUMENT KNOB (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) INNER SHAFT W/STOPS-STANDARD FOR ACIS IMPLANT INSERTER. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10537900 ↗