My3D® Personalized Pelvic Reconstruction LS-50040-04MRecalls & reported problems

Onkos Surgical, Inc. · Locking Cortical Bone Screw 5.0x40MM · Class 2 · Implant

All models of My3D Personalized Pelvic Reconstruction (20)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI B278LS5004004M0), received between Apr 12, 2024 and Dec 11, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Insufficient Device Problem Information2

Patient problems

No Clinical Signs, Symptoms or Conditions1
Unspecified Infection1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjuryDec 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A CUSTOM ONKOS INTERCALARY TIBIA CONSTRUCT EXPERIENCED SUBSIDENCE AT THE PROXIMAL PORTION. THE PATIENT'S INDEX PROCEDURE TOOK PLACE ON (B)(6) 2024. THE PATIENT WAS REVISED ON (B)(6) 2024 TO AUGMENT THE PROXIMAL PORTION WITH BONE CEMENT AND REPLACE THE FOUR PROXIMAL SCREWS. THIS EVENT WILL BE REPORTABLE AS A SERIOUS INJURY, DUE TO THE REVISION PROCEDURE. THIS REPORT CAPTURES THE MY3D PERSONALIZED PELVIC RECONSTRUCTION CORTICAL LOCKING BONE SCREW, FOURTH OF THE FOUR PROXIMAL SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20903401 ↗
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 19098119 ↗

Device details

UDI-DI	`B278LS5004004M0`
Brand	My3D® Personalized Pelvic Reconstruction
Model	LS-50040-04M
Company	Onkos Surgical, Inc.
Product code	LPH · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 6, 2025

Device type (GMDN): Orthopaedic bone screw (non-sliding)

A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented devices

PINNACLE 1217-25-500
Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
735 reports
NA 1365-52-000
Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
683 reports
APEX 1246-03-000
Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
3 deaths613 reports
PINNACLE 1217-20-500
Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
2 deaths590 reports
PINNACLE 1217-30-500
Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
1 death484 reports
NA 1365-53-000
Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
404 reports
PINNACLE ALTRX 1221-36-054
Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
388 reports
PINNACLE ALTRX 1221-32-050
Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
386 reports

All Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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