My3D® Personalized Pelvic Reconstruction CS-65015-04MRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI B278CS6501504M0), received between Mar 1, 2024 and Apr 12, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT HAD AN ALLEGED INFECTION AND UNDERWENT A REVISION PROCEDURE TO EXPLANT ONKOS DEVICES. THE PATIENT'S PRIMARY SURGERY OCCURED ON (B)(6) 2023, WHERE THE PATIENT WAS IMPLANTED WITH A MY3D PELVIC IMPLANT, WHICH WAS APPROVED THROUGH THE COMPASSIONATE USE PATHWAY. THE PATIENT WAS ALSO IMPLANTED WITH MY3D PERSONALIZED PELVIC RECONSTRUCTION CANCELLOUS BONE SCREWS, MY3D PERSONALIZED PELVIC RECONSTRUCTION LOCKING CORTICAL BONE SCREWS, AND A MY3D PERSONALIZED PELVIC RECONSTRUCTION APICAL HOLE PLUG. AS THE PATIENT UNDERWENT A REVISION PROCEDURE, THIS EVENT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY. THIS REPORT CAPTURES A MY3D PERSONALIZED PELVIC RECONSTRUCTION CANCELLOUS BONE SCREW.

  Patient problems: Unspecified Infection

  MAUDE report 19098094 ↗
• InjuryMar 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY P. MEDINA, AN ONKOS SALES REPRESENTATIVE, THAT THE 64-YEAR-OLD FEMALE PATIENT FELL, AND THE FORCE OF THE FALL CAUSED THE ACETABULAR RECONSTRUCTION IMPLANT TO LOOSEN. A REVISION SURGERY TO PROPERLY FIXATE THE IMPLANT TOOK PLACE ON (B)(6) 2023, DURING WHICH THE SURGEON DISCOVERED THAT THERE WAS AN INFECTION. THE IMPLANT AND ALL RELATED HARDWARE WERE SUBSEQUENTLY EXPLANTED, AND STEPS WERE TAKEN TO ELIMINATE THE INFECTION. THE PRIMARY SURGERY TO INSERT THE ACETABULAR RECONSTRUCTION IMPLANT TOOK PLACE ON (B)(6) 2023. THE PATIENT REPORTEDLY FELL APPROXIMATELY ONE MONTH AFTER THE PRIMARY SURGERY DATE.

  Patient problems: Medical device site infection

  MAUDE report 18818464 ↗
• InjuryMar 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY P. MEDINA, AN ONKOS SALES REPRESENTATIVE, THAT THE 64-YEAR-OLD FEMALE PATIENT FELL, AND THE FORCE OF THE FALL CAUSED THE ACETABULAR RECONSTRUCTION IMPLANT TO LOOSEN. A REVISION SURGERY TO PROPERLY FIXATE THE IMPLANT TOOK PLACE ON (B)(6) 2023, DURING WHICH THE SURGEON DISCOVERED THAT THERE WAS AN INFECTION. THE IMPLANT AND ALL RELATED HARDWARE WERE SUBSEQUENTLY EXPLANTED, AND STEPS WERE TAKEN TO ELIMINATE THE INFECTION. THE PRIMARY SURGERY TO INSERT THE ACETABULAR RECONSTRUCTION IMPLANT TOOK PLACE ON (B)(6) 2023. THE PATIENT REPORTEDLY FELL APPROXIMATELY ONE MONTH AFTER THE PRIMARY SURGERY DATE.

  Patient problems: Medical device site infection

  MAUDE report 18818440 ↗

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