Pulsar Expandable PLIF System 2210-0941Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08800104089626), received between Jul 16, 2025 and Jul 16, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Collapse” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2025Collapse; Collapse

  [SUPPLIER] HAD A BRIEF DISCUSSION WITH THE SURGEON AND THE REPRESENTATIVE ABOUT THE CAGE COLLAPSING 6 MONTHS POST OP. THE SURGEON EXPLAINED THAT HE IMPLANTED THE EXPANDABLE CAGE, INITIALLY EXPANDED IT AND TORQUED IT OUT, THEN ALLOWED IT TO SIT MOMENTARILY TO BUILD PRESSURE. HE SUBSEQUENTLY RE-ENGAGED TO FURTHER EXPAND AND TORQUE IT IN AN EFFORT TO ACHIEVE ADDITIONAL HEIGHT. THE TORQUEING OF THE CAGE MULTIPLE TIMES WITH DIFFERENT HEIGHTS IS NOT COMPLIANT WITH THE IFU. DURING THE ROUTINE 6 MONTH FOLLOW UP, XRAYS WERE TAKEN AND THE SURGEON SAW THAT THE IMPLANT WAS NO LONGER EXPANDED. THE PATIENT HAD NO CLINICAL SYMPTOMS (PAIN, LOSS OF FUNCTION, INC). THEREFORE, THE SURGEON CONCLUDED NO INTERVENTION WAS REQUIRED.

  Patient problems: Failure of Implant

  MAUDE report 22519102 ↗