My3D® Personalized Pelvic Reconstruction LS-50026-04MRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI B278LS5002604M0), received between Apr 12, 2024 and Apr 12, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

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 LOCKING CORTICAL BONE SCREW.

  Patient problems: Unspecified Infection

  MAUDE report 19098111 ↗
• 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 LOCKING CORTICAL BONE SCREW.

  Patient problems: Unspecified Infection

  MAUDE report 19098108 ↗
• 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 LOCKING CORTICAL BONE SCREW.

  Patient problems: Unspecified Infection

  MAUDE report 19098107 ↗