My3D® Personalized Pelvic Reconstruction PV-ACREC-04MRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI B278PVACREC04M0), received between May 12, 2023 and Sep 5, 2025 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH AN ONKOS PELVIC RECONSTRUCTION CASE EXPERIENCED AN ALLEGED INFECTION. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025 TO EXPLANT THE PELVIC RECONSTRUCTION. THIS REPORT CAPTURES THE PELVIC IMPLANT.THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE EXPLANTATION. THIS REPORT CAPTURES THE PELVIC IMPLANT.

  Patient problems: Unspecified Infection

  MAUDE report 22985390 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH AN ONKOS PELVIC RECONSTRUCTION CASE EXPERIENCED AN ALLEGED INFECTION. ADDITIONAL DETAILS ARE NOT KNOWN AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 22985216 ↗
• MalfunctionAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ONKOS ACETABULAR PELVIC IMPLANT DESIGNED IN CASE (B)(4) WAS UNABLE TO FIT INTO THE PATIENT'S ANATOMY; THEREFORE, AN OFF-THE-SHELF OPTION WAS USED INSTEAD. THE LENGTH OF SURGICAL DELAY IS NOT KNOWN. THIS EVENT WILL BE REPORTED AS A MALFUNCTION, AS THE EVENT COULD HAVE CONTRIBUTED TO A SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22841636 ↗
• InjuryJun 23, 2025Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PELVIC IMPLANT DESIGNED IN CASE(B)(4) WAS UNABLE TO FIT INTO THE PATIENT'S ANATOMY; THEREFORE, AN OFF-THE-SHELF OPTION WAS IMPLANTED INSTEAD. THIS EVENT RESULTED IN APPROXIMATELY 60-MINUTE DELAY. THIS REPORT CAPTURES THE MY3D PERSONALIZED PELVIC RECONTRUCTION IMPLANT. THIS EVENT WILL BE REPORTED TO THE FDA AS A SERIOUS INJURY DUE TO THE 60-MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 22309904 ↗
• InjuryMay 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE WAS DIFFICULTY IMPLANTING AN ONKOS PELVIC RECONSTRUCTION IMPLANT, RESULTING IN THE SURGEON USING AN ALTERNATE PELVIC IMPLANT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE ALTERNATE DEVICE. THIS EVENT WILL BE REPORTED TO THE FDA AS A MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21998451 ↗
• InjuryJan 5, 2024Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S MY3D PERSONALIZED PELVIC RECONSTRUCTION ACETABULAR IMPLANT LOOSENED. THE PATIENT'S INDEX PROCEDURE OCCURRED ON (B)(6) 2023, AND THE PATIENT WAS REVISED ON (B)(6) 2023. DETAILS REGARDING THE REVISION SURGERY ARE NOT KNOWN AT THIS TIME. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Medical device site infection; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18451230 ↗
• MalfunctionDec 12, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING A MY3D PERSONALIZED PELVIC RECONSTRUCTION CASE, THE SURGEON HAD DIFFICULTY FITTING THE IMPLANT INTO THE PATIENT ANATOMY (SPECIFICALLY, GETTING BOTH THE ILIAC AND ISCHIAL FLANGES TO FULLY SIT DOWN ON BONE AT THE SAME TIME). FOR THE IMPLANT TO HAVE GOOD FIT SUPERIORLY, THE ISCHIAL FLANGE WAS CUT OFF INTRAOPERATIVELY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A LESS THAN 30 MINUTE SURGICAL DELAY. THIS EVENT WILL BE REPORTED TO THE FDA AS A MALFUNCTION AS THERE IS POTENTIAL FOR THE IMPLANT TO LOOSEN AND CONTRIBUTE TO A SERIOUS INJURY IN THE FURTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18315355 ↗
• MalfunctionAug 25, 2023Material Discolored; Insufficient Device Problem Information; Unexpected Color; Material Discolored; Insufficient Device Problem Information; Unexpected Color

  IT WAS REPORTED THAT A PELVIC IMPLANT WAS OBSERVED TO BE DISCOLORED POST-STERILIZATION AT THE HOSPITAL FOR A SURGERY ON (B)(6) 2023. IT WAS REPORTED THAT THE METAL IMPLANT WAS STERILIZED WITH THE PLASTIC COMPONENTS. THE DEVICE WAS IMPLANTED IN THE PATIENT DURING THIS PROCEDURE. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

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

  MAUDE report 17625143 ↗
• MalfunctionJun 9, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED ON (B)(6) 2023 THAT A MY3D PERSONALIZED PELVIC RECONSTRUCTION IMPLANT WAS UNABLE TO FIT AS INTENDED, DUE TO ISSUES REMOVING PREVIOUS HARDWARE. THE PREVIOUS HARDWARE WAS AN AUGMENT FROM ANOTHER COMPANY WHICH WAS INTENDED TO BE REMOVED, BUT IT WAS LEFT IN THE PATIENT AS IT WAS DIFFICULT TO REMOVE INTRA-OPERATIVELY. AS A RESULT, THE ACETABULAR RECONSTRUCTION IMPLANT WAS SLIGHTLY PROUD OF THE INTENDED LOCATION. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITH A 45 MINUTE SURGICAL DELAY. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A MALFUNCTION, AS THE ISSUE COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IN THE FUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17101184 ↗
• MalfunctionJun 9, 2023Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED ON (B)(6) 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 ACETABULAR RECONSTRUCTION IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17101111 ↗
• MalfunctionMay 12, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING A SURGERY ON (B)(6) 2023, A SURGEON REPORTED HAVING DIFFICULTY FITTING AN ACETABULAR RECONSTRUCTION IMPLANT INTO THE PATIENT'S ANATOMY. IN ORDER TO FIT THE IMPLANT INTO THE PATIENT'S ANATOMY, THE IMPLANT WAS MODIFIED INTRA-OPERATIVELY- THE ISCHIAL FLANGE WAS CUT OFF USING A METAL CUTTING BURR, RESULTING IN THE IMPLANT HAVING ONLY ONE FLANGE. AFTER MODIFICATION, THE PROCEDURE WAS ABLE TO BE COMPLETED. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A MALFUNCTION, AS THE ISSUE COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924602 ↗

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