FORZA 89-0153Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18257200077076), received between Nov 11, 2025 and Nov 11, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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

Recent adverse event reports

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

• MalfunctionNov 11, 2025Material Fragmentation; Material Fragmentation

  ON OCTOBER 30TH, I WAS SUPPORTING A SPINAL SURGERY CASE AT (B)(6). THE SURGEON PERFORMED A THREE-LEVEL SPONDYLOLISTHESIS PROCEDURE AND PLANNED TO USE FORZA TI CAGES AT TWO LEVELS. NORMALLY, THE CLINIC USES FORZA PTC CAGES, BUT DUE TO LIMITED AVAILABILITY IN CERTAIN SIZES, WE DECIDED TO USE THE FORZA TI FOR THIS CASE. DURING THE PROCEDURE, THE SCRUB NURSE ATTACHED A FORZA TI CAGE TO THE 11MM CURVED IMPLANT SHAFT. WHEN THE SURGEON BEGAN INSERTING THE IMPLANT WITH THE MALLET, THE CAGE BECAME LOOSE. UPON REMOVAL, WE OBSERVED THAT PART OF THE SIDE TEETH OF THE CURVED IMPLANT SHAFT HAD BROKEN OFF. IN ADDITION, THE THREADED INSERT FRACTURED, AND A FRAGMENT REMAINED LODGED INSIDE THE CAGE WHICH MADE IT UNUSABLE. THE SURGEON HAD TO LOCATE AND RETRIEVE THE MISSING METAL FRAGMENTS FROM INSIDE THE PATIENT, WHICH FORTUNATELY WERE ALL FOUND. AFTER THIS INCIDENT, THE SURGEON ATTEMPTED INSERTION AGAIN USING THE OTHER 11MM CURVED IMPLANT SHAFT AND A NEW CAGE OF THE SAME SIZE. ALTHOUGH THE CAGE ATTACHED PROPERLY, THE SECOND IMPLANT SHAFT BROKE IN THE SAME MANNER AS THE FIRST ONE. ADDITIONALLY, DUE TO A MIX-UP, THE SCRUB NURSE MISTAKENLY HANDED THE 9MM TAMP INSTEAD OF THE CORRECT 11MM TAMP. THIS RESU

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23524057 ↗