Idys™- TLIF TiVac 41532909-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03700780628643), received between Jan 31, 2020 and Jan 17, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2024Material Fragmentation; Material Fragmentation

  SURGEON WAS ON THE PATIENT'S RIGHT AT L2-3 USING 9MM TI COATED PEEL BANANA CAGE (REF= (B)(4)// LOT = N1A9X-N113Y). IMPLANT WAS IMPACTED INTO DISC SPACE AND ARTICULATED PROPERLY. THE WHEEL OF THE INSERTER WAS TURNED TO DISENGAGE THE IMPLANT AND A SLAP HAMMER WAS USED TO GET INSERTER OUT OF DISC SPACE. THE PROXIMAL TANTALUM MARKER PORTION OF THE IMPLANT BROKE FROM THE REST OF THE IMPLANT DURING THIS. THE BROKEN PIECE WAS RETRIEVED AND REMOVED FROM THE FIELD. THERE WAS NO HARM TO THE PATIENT AND NO DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18525907 ↗
• MalfunctionJan 9, 2024Material Fragmentation; Material Fragmentation

  SURGEON WAS ON THE PATIENT'S RIGHT AT L2-3 USING 9MM TI COATED PEEL BANANA CAGE (REF = (B)(4)/LOT = N1A9X-N113Y). IMPLANT WAS IMPACTED INTO DISC SPACE AND ARTICULATED PROPERLY. THE WHEEL OF THE INSERTER WAS TURNED TO DISENGAGE THE IMPLANT AND A SLAP HAMMER WAS USED TO GET INSERTER OUT OF DISC SPACE. THE PROXIMAL TANTALUM MARKER PORTION OF THE IMPLANT BROKE FROM THE REST OF THE IMPLANT DURING THIS.THE BROKEN PIECE WAS RETRIEVED AND REMOVED FROM THE FIELD. THERE WAS NO HARM TO THE PATIENT AND NO DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18480347 ↗
• MalfunctionSep 14, 2023Material Fragmentation; Material Fragmentation

  THE SURGEON WAS ON THE PATIENT'S RIGHT AT L4-5 USING A 9MM TI COATED PEEK BANANA CAGE WITH THE 25-DEGREE ANGLED INSERTER. WHILE IMPACTING INTO THE DISC SPACE, BEFORE ARTICULATING THE INSERTER, THE PROXIMAL TANTALUM MARKER PORTION OF THE CAGE BROKE FROM THE REST OF THE CAGE. HE WAS ABLE TO RETRIEVE THE BROKEN PORTION AND REMOVE IT FROM THE DISC SPACE. HE THEN USED A TAMP/PUSHER TO POSITION THE REST OF THE CAGE ACCORDINGLY. THERE WAS NOT A SIGNIFICANT DELAY TO THE CASE, OR ANY HARM DONE TO THE PATIENT BECAUSE OF THE INCIDENT. ALL THE BROKEN PIECES OF THE IMPLANT WERE REMOVED FROM THE PATIENT AND DISCARDED BY THE SURGICAL STAFF AND CAN'T BE SENT BACK FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17746225 ↗
• MalfunctionJan 31, 2020Break; Break

  THE TLIF CAGE BROKE WHEN BEING MANEUVERED INTO POSITION AFTER THE CAGE WAS INITIALLY INSERTED THROUGH THE ANTERIOR PORTION OF THE DISC. IT WAS REPORTED THAT THE CAGE SHEERED OFF IN HALF AS THE SURGEON WAS PULLING BACK ON THE INSERTER. AFTER SEVERAL ATTEMPTS, THE 2 PIECES WERE REMOVED. A SECOND CAGE WAS SUCCESSFULLY INSERTED. NO PATIENT HARM WAS REPORTED AND THE SURGERY WAS ABLE TO BE COMPLETED WITHOUT FURTHER INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9655858 ↗