VSP Orthopedics Allograft Tibia Cutting GuideRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816847021845), received between Sep 10, 2020 and Sep 10, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.

• InjurySep 10, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  FOR A VSP ORTHOPEDICS TIBIA RESECTION AND ALLOGRAFT RECONSTRUCTION PROCEDURE, THE SURGEON NOTED THE FOLLOWING ISSUES: THE ALLOGRAFT TIBIA CUTTING GUIDE DID NOT FIT THE ALLOGRAFT. THE PATIENT'S NATIVE REMAINING BONY ANATOMY AT THE PROXIMAL END OF THE TIBIA FRACTURED DURING THE CUTTING PROCESS USING THE PATIENT TIBIA CUTTING GUIDE. INVESTIGATION AT THIS TIME REVEALED NO ROOT CAUSE ATTRIBUTED TO 3D SYSTEMS FOR THE ABOVE ISSUES. NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. AN INCORRECT REVISION OF THE CASE REPORT WAS PROVIDED TO THE SURGEON. THIS WAS IDENTIFIED AND CORRECTED PRIOR TO SURGERY.

  Patient problems: Bone Fracture(s)

  MAUDE report 10518178 ↗