FORZA 89-0112Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18257200076970), received between Jan 5, 2018 and Jan 5, 2018 — classified as 1 malfunction.

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

• MalfunctionJan 5, 2018Adverse Event Without Identified Device or Use Problem

  INFORMATION PROVIDED STATES THAT DURING THE CASE THE INSERTER TO IMPLANT THE 10MM INTERBODY WAS USED. AFTER SEVERAL IMPACTIONS THE SURGEON FELT THAT THE INSERTER WAS NO LONGER ATTACHED TO THE IMPLANT. UPON FURTHER INSPECTION IT WAS NOTED THE IMPLANT HAD BEEN PASSED THROUGH THE DISC SPACE THROUGH THE ANNULUS AND ANTERIOR TO THE SPINE. THE SURGEON PLACED A SECOND GRAFT, REPOSITIONED THE PATIENT AND CALLED IN AN ACCESS SURGEON TO REMOVE THE FIRST GRAFT FROM AN ALIF APPROACH. THIS REQUIRED A SECOND INCISION SITE ANTERIORLY AND AN INCREASE IN THE SURGERY TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7167732 ↗