ACP 18008113Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00195377009418), received between Jun 21, 2021 and Apr 1, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Migration” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TWO (2) LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE AT C5-C6 USING AN INTERBODY AND ANTERIOR PLATING CONSTRUCT. SUBSEQUENTLY, A POST-OPERATIVE EVALUATION PERFORMED APPROXIMATELY TWO (2) WEEKS LATER IDENTIFIED ONE OF THE ANTERIOR PLATE SCREWS IN THE C6 VERTEBRAL BODY HAD BACKED OUT. THE PATIENT INITIALLY REPORTED DIFFICULTY SWALLOWING; HOWEVER, AN EVALUATION AT THREE (3) WEEKS POST-OP IDENTIFIED THE PATIENT'S CONDITION TO BE IMPROVING. THERE IS NO INTENT TO REVISE THE CONSTRUCT AT THIS TIME. NO FURTHER PATIENT IMPACT WAS REPORTED.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 13972436 ↗
• MalfunctionAug 12, 2021Migration; Migration

  ON (B)(6) 2021 PATIENT UNDERWENT A ANTERIOR CERVICAL DISC FUSION PROCEDURE FROM C6-C7. ON (B)(6) 2021 IT WAS DISCOVERED REPORTED THE PATIENT WAS CONTINUING TO HAVE MUSCLE SPASMS IN HER TRAPEZIUS, CONTINUED LEFT ARM PAIN AS WELL AS BILATERAL HAND TINGLING THAT RETURNS MOSTLY WITH ACTIVITY. ON (B)(6) 2021 RADIOGRAPHS SHOWED THE INFERIOR ASPECT OF PLATE MIGRATED APPROXIMATELY 1MM. THE DEVICE REMAINS IN SITU AND PATIENT STATUS WILL CONTINUE TO BE MONITORED. NO REVISION IS PLANNED AT THIS TIME.

  Patient problems: Neck Pain

  MAUDE report 12314233 ↗
• MalfunctionJun 21, 2021Migration; Migration

  ON (B)(6) 2021 A PATIENT UNDERWENT A ANTERIOR CERVICAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO ISSUE. ON (B)(6) 2021 DURING A ROUTINE POST-OP FOLLOW UP RADIOGRAPH IMAGED SHOWED WHAT APPEARED TO BE THE A PLATE SCREW PULL OUT BUT WAS INCONCLUSIVE. ON (B)(6) ANOTHER FOLLOW UP OCCURRED WHERE RADIOGRAPH CONFIRMED THE SCREW PULL OUT. THE PATIENT IS ASYMPTOMATIC SO THE DEVICE WILL REMAIN IN-SITU AND THE PATIENTS STATUS WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12035648 ↗