My3D® Personalized Pelvic Reconstruction PV-GUIDE-04NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B278PVGUIDE04N0), received between Aug 11, 2023 and Aug 11, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Positioning Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K212815); they may or may not involve this specific model.

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.

• InjuryAug 11, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING A MY3D PERSONALIZED PELVIC RECONSTRUCTION CASE, THE SURGEON HAD DIFFICULTY REAMING OUT THE BONE WITH THE CUSTOMIZED PELVIC GUIDE (REAMING GUIDE). IT WAS REPORTED THAT THERE WAS DIFFICULTY IN THE ORIENTATION OF THE GUIDE WHILE REAMING, AND IT RESULTED IN OVER AN HOUR SURGICAL DELAY. DUE TO THE LENGTH OF SURGICAL DELAY, THIS EVENT WILL BE REPORTED TO THE FDA AS A SERIOUS INJURY. THIS RECORD CAPTURES THE CUSTOMIZED PELVIC GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17515629 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K212815. One submission often covers many models, so check the product and lot details in each record.

• Z-0091-2027 · Jul 24, 2026 · Open, Classified
  Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
• Z-0090-2027 · Jul 24, 2026 · Open, Classified
  Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M