My3D® Personalized Pelvic Reconstruction AM-M3DMD-04NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI B278AMM3DMD04N0), received between Jun 9, 2023 and Jun 9, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing Problem” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2023Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED ON 12 MAY 2023 THAT THE PELVIC IMPLANT AND PLASTIC INSTRUMENTS FOR A MY3D PERSONALIZED PELVIC RECONSTRUCTION CASE WERE STERILIZED TOGETHER. ACCORDING TO THE MY3D PERSONALIZED PELVIC RECONSTRUCTION IFU, THE METAL IMPLANT AND PLASTIC ACCESSORIES ARE NOT INTENDED TO BE STERILIZED TOGETHER. THE CASE CONSISTED OF TWO CUSTOMIZED PELVIC GUIDES AND ONE ACETABULAR RECONSTRUCTION IMPLANT. THERE WERE NO ISSUES WITH DEVICES AFTER STERILIZATION, AND THE PROCEDURE WAS ABLE TO BE COMPLETED SUCESSFULLY. THIS EVENT WILL BE REPORTED TO THE FDA AS A MALFUNCTION, AS THE IMPACT OF STERILIZING THESE COMPONENTS TOGETHER IS UNKNOWN. THIS RECORD CAPTURES THE SECOND OF THE TWO CUSTOMIZED PELVIC GUIDES IN THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17101110 ↗
• MalfunctionJun 9, 2023Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED ON 12 MAY 2023 THAT THE PELVIC IMPLANT AND PLASTIC INSTRUMENTS FOR A MY3D PERSONALIZED PELVIC RECONSTRUCTION CASE WERE STERILIZED TOGETHER. ACCORDING TO THE MY3D PERSONALIZED PELVIC RECONSTRUCTION IFU, THE METAL IMPLANT AND PLASTIC ACCESSORIES ARE NOT INTENDED TO BE STERILIZED TOGETHER. THE CASE CONSISTED OF TWO ANATOMIC MODELS AND ONE ACETABULAR RECONSTRUCTION IMPLANT. THERE WERE NO ISSUES WITH DEVICES AFTER STERILIZATION, AND THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY. THIS EVENT WILL BE REPORTED TO THE FDA AS A MALFUNCTION, AS THE IMPACT OF STERILIZING THESE COMPONENTS TOGETHER IS UNKNOWN. THIS RECORD CAPTURES THE FIRST OF THE TWO ANATOMIC MODELS IN THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17101109 ↗

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