My3D® Personalized Pelvic Reconstruction DR-43200-04NRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI B278DR4320004N0), received between May 10, 2024 and May 23, 2024 — classified as 5 malfunctions.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY (B)(6), AN ONKOS SALES REPRESENTATIVE, THAT TWO 4.3 X 200MM DRILL BITS FRACTURED INTRAOPERATIVELY ON (B)(6) 2024 IN THE PROCESS OF IMPLANTING A MY3D ACETABULAR RECONSTRUCTION IMPLANT (CASE # (B)(6)) INTO A 79-YEAR-OLD MALE PATIENT. DRILL BIT FRAGMENTS REPORTEDLY REMAIN IMPLANTED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19387907 ↗
• MalfunctionMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY (B)(4), AN ONKOS SALES REPRESENTATIVE, THAT TWO 4.3 X 200MM DRILL BITS FRACTURED INTRAOPERATIVELY ON (B)(6) 2024 IN THE PROCESS OF IMPLANTING A MY3D ACETABULAR RECONSTRUCTION IMPLANT (CASE # (B)(4)) INTO A 79-YEAR-OLD MALE PATIENT. DRILL BIT FRAGMENTS REPORTEDLY REMAIN IMPLANTED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19387906 ↗
• MalfunctionMay 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY (B)(6), AN ONKOS SALES REPRESENTATIVE, THAT A 4.3 X 200MM DRILL BIT FRACTURED INTRAOPERATIVELY IN THE PROCESS OF IMPLANTING A MY3D ACETABULAR RECONSTRUCTION IMPLANT (CASE # (B)(4)). THE DRILL BIT FRAGMENT(S) REPORTEDLY REMAIN IMPLANTED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19293812 ↗
• MalfunctionMay 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY (B)(6), AN ONKOS SALES REPRESENTATIVE, THAT A 4.3 X 200MM DRILL BIT FRACTURED INTRAOPERATIVELY IN THE PROCESS OF IMPLANTING A MY3D ACETABULAR RECONSTRUCTION IMPLANT (CASE # (B)(6)). THE DRILL BIT FRAGMENT(S) REPORTEDLY REMAIN IMPLANTED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19293567 ↗
• MalfunctionMay 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY (B)(4), AN ONKOS SALES REPRESENTATIVE, THAT A 4.3 X 200MM CALIBRATED DRILL BIT FRACTURED INTRAOPERATIVELY ON (B)(6) 2024 WHILE THE SURGEON, DOCTOR (B)(6), WAS DRILLING SCREW HOLES TO IMPLANT A MY3D PELVIC RECONSTRUCTION SYSTEM (CASE # (B)(6)) INTO A 42-YEAR-OLD FEMALE PATIENT. THE DRILL BIT FRAGMENTS WERE REPORTEDLY REMOVED FROM THE PATIENT BY DOCTOR (B)(6) PRIOR TO COMPLETION OF THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19293448 ↗

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