My3D® Personalized Pelvic Reconstruction CS-65020-04MRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI B278CS6502004M0), received between Jun 12, 2024 and Jun 12, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

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

  IT WAS REPORTED THAT A PATIENT HAD AN ALLEGED INFECTION AND ELECTED TO HAVE AN AMPUTATION. THIS PATIENT WAS IMPLANTED WITH A MY3D PERSONALIZED SOLUTIONS PELVIS IMPLANT AND 10 MY3D PERSONALIZED PELVIC RECONSTRUCTION CANCELLOUS BONE SCREWS. THE PATIENT'S INDEX SURGERY OCCURRED ON (B)(6) 2023. ALL IMPLANTED DEVICES WERE EXPLANTED ON (B)(6) 2024. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE. THIS REPORT CAPTURES ONE MY3D PERSONALIZED PELVIC RECONSTRUCTION CANCELLOUS BONE SCREW.

  Patient problems: Unspecified Infection

  MAUDE report 19522197 ↗
• InjuryJun 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT HAD AN ALLEGED INFECTION AND ELECTED TO HAVE AN AMPUTATION. THIS PATIENT WAS IMPLANTED WITH A MY3D PERSONALIZED SOLUTIONS PELVIS IMPLANT AND 10 MY3D PERSONALIZED PELVIC RECONSTRUCTION CANCELLOUS BONE SCREWS. THE PATIENT'S INDEX SURGERY OCCURRED ON (B)(6) 2023. ALL IMPLANTED DEVICES WERE EXPLANTED ON (B)(6) 2024. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE. THIS REPORT CAPTURES ONE MY3D PERSONALIZED PELVIC RECONSTRUCTION CANCELLOUS BONE SCREW.

  Patient problems: Unspecified Infection

  MAUDE report 19522195 ↗

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