My3D® Personalized Pelvic Reconstruction CS-65090-04MRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI B278CS6509004M0), received between Oct 11, 2023 and Oct 11, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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.

• InjuryOct 11, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2023, THAT A PATIENT EXPERIENCED A FRACTURE OF SCREWS WHICH CAUSED A DISASSOCIATION OF THE IMPLANT FROM THE BONE AND THAT A REVISION SUGERY WAS BEING PLANNED TO CORRECT THIS ISSUE. NO ADDTITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17917359 ↗
• InjuryOct 11, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2023, THAT A PATIENT EXPERIENCED A FRACTURE OF SCREWS WHICH CAUSED A DISASSOCIATION OF THE IMPLANT FROM THE BONE AND THAT A REVISION SURGERY WAS BEING PLANNED TO CORRECT THIS ISSUE. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17917358 ↗

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