My3D® Personalized Pelvic Reconstruction CS-65055-04MRecalls & reported problems

Onkos Surgical, Inc. · CANCELLOUS BONE SCREW, 6.5MM DIA x 55MM LENGTH · Class 2

All models of My3D Personalized Pelvic Reconstruction (20)

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

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B278CS6505504M0), received between Dec 11, 2024 and Dec 11, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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.

Reports received per month

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

Most reported problems

Device problems

Insufficient Device Problem Information1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 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 INTERCALLARY 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 CANCELLOUS BONE SCREW, SECOND OF THE FOUR PROXIMAL SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20903368 ↗

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

Device details

UDI-DI	`B278CS6505504M0`
Brand	My3D® Personalized Pelvic Reconstruction
Model	CS-65055-04M
Company	Onkos Surgical, Inc.
Product code	LPH · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Class	Class 2
FDA submission	K212815
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 19, 2024

Device type (GMDN): Orthopaedic bone screw, non-bioabsorbable, non-sterile

A small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

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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