VSP Orthopedics Allograft Orthopedic ModelRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816847022453), received between Mar 8, 2022 and Mar 8, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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.

• InjuryMar 8, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  DURING A VSP ORTHOPAEDICS TIBIA RESECTION AND ALLOGRAFT RECONSTRUCTION PROCEDURE, THE GUIDES PROVIDED BY 3D SYSTEMS DID NOT PRODUCE AN ACCURATE REPRESENTATION OF THE PLANNED ALLOGRAFT USED IN SURGERY. THE SURGEON NOTED THAT THE PHYSICAL ALLOGRAFT AND THE ALLOGRAFT MODEL WERE MIRRORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13696983 ↗