TPLIF Interbody System M2-P2410410-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M695M2P2410410S0), received between Jan 8, 2026 and Jan 8, 2026 — classified as 1 injury.

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.

• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  ADVERSE EVENT IDENTIFIED AS PART OF A RETROSPECTIVE CLINICAL STUDY: AT 12.5 MONTHS POST OPERATIVE, THE SUBJECT DEVELOPED RIGHT SIDED WEAKNESS AND LOSS OF SENSATION LEADING TO ADDITIONAL SURGERY (RIGHT L4/L5, L5/S1 FORAMINOTOMY). THE EVENT WAS CONTINUOUS, SEVERE, SERIOUS, AND UNANTICIPATED. THE SITE STATED THAT THE EVENT COULD HAVE HAD A POSSIBLE RELATIONSHIP TO THE SUBJECT DEVICE, BUT THE PATIENT RECOVERED WITHOUT SEQUELAE. MORE NOTES ON THE EVENT STATE THE SUBJECT HAD RIGHT SIDED WEAKNESS THAT PROGRESSED TO THE INABILITY TO LIFT THE RIGHT FOOT WITHOUT ASSISTANCE. PATIENT WAS INITIALLY REFERRED TO PAIN MANAGEMENT FOR RIGHT SIDED L4/L5, L5/S1 TRANSFORAMINAL INJECTIONS, BUT THE PATIENT SAW NO IMPROVEMENT IN SYMPTOMS AND WAS THEN TREATED SURGICALLY VIA RIGHT L4/L5, L5/S1 FORAMINOTOMY. SYMPTOMS IMPROVED FOLLOWING THIS PROCEDURE, NO FURTHER MENTION OF SYMPTOMS PROMPTED INTERVENTION.

  Patient problems: Neuropathy

  MAUDE report 24005230 ↗