My3D Personalized Pelvic ReconstructionRecalls & reported problems across all models
Onkos Surgical, Inc. · 20 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 52
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls
- 0
We found 20 models of My3D Personalized Pelvic Reconstruction by Onkos Surgical, Inc. in the FDA's device registry (GUDID). Together they are named in 52 adverse event reports in the FDA's MAUDE database, received between May 12, 2023 and Sep 16, 2025 — classified as 38 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (31 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported My3D Personalized Pelvic Reconstruction problems
Device problems
- Insufficient Device Problem Information31
- Adverse Event Without Identified Device or Use Problem15
- Positioning Problem4
- Device Reprocessing Problem3
- Fracture2
- Device Dislodged or Dislocated1
- Material Deformation1
- Material Discolored1
Patient problems
- Unspecified Infection27
- No Clinical Signs, Symptoms or Conditions24
- Insufficient Information3
- Medical device site infection3
My3D Personalized Pelvic Reconstruction models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- My3D® Personalized Pelvic Reconstruction PV-ACREC-04MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented11 reports
- My3D® Personalized Pelvic Reconstruction CS-65025-04MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented6 reports
- My3D® Personalized Pelvic Reconstruction DR-43200-04NProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented5 reports
- My3D® Personalized Pelvic Reconstruction LS-50014-04MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented4 reports
- My3D® Personalized Pelvic Reconstruction CS-65015-04MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented3 reports
- My3D® Personalized Pelvic Reconstruction LS-50026-04MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented3 reports
- My3D® Personalized Pelvic Reconstruction AM-M3DMD-04NProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2 reports
- My3D® Personalized Pelvic Reconstruction CS-65020-04MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2 reports
- My3D® Personalized Pelvic Reconstruction CS-65075-04MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2 reports
- My3D® Personalized Pelvic Reconstruction CS-65090-04MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2 reports
- My3D® Personalized Pelvic Reconstruction CS-65095-04MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2 reports
- My3D® Personalized Pelvic Reconstruction LS-50040-04MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2 reports
- My3D® Personalized Pelvic Reconstruction AP-38016-04MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
- My3D® Personalized Pelvic Reconstruction CS-65050-04MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
- My3D® Personalized Pelvic Reconstruction CS-65055-04MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
- My3D® Personalized Pelvic Reconstruction CS-65080-04MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
- My3D® Personalized Pelvic Reconstruction CS-65100-04MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
- My3D® Personalized Pelvic Reconstruction DR-432NS-04NProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
- My3D® Personalized Pelvic Reconstruction LS-50060-04MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
- My3D® Personalized Pelvic Reconstruction PV-GUIDE-04NProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
Recent My3D Personalized Pelvic Reconstruction adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2025: THE PATIENT IMPLANTED WITH MY3D PELVIC RECONSTRUCTION SYSTEM CASE (B)(4) HAD AN ALLEGED INFECTION. THE PATIENT RECEIVED A WASHOUT PROCEDURE- NO DEVICES WERE EXPLANTED DURING THIS PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 23067606 ↗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 ↗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, THIRD OF THE FOUR PROXIMAL SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20903921 ↗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 ↗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, ONE OF THE FOUR PROXIMAL SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20903369 ↗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 ↗InjuryJun 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A PATIENT HAD AN ALLEGED INFECTION AND ELECTED TO HAVE AN AMPUTATION. THIS PATIENT WAS IMPLANTED WITH A MY3D PERSONALIZED SOLUTIONS PELVIS IMPLANT AND 10 MY3D PERSONALIZED PELVIC RECONSTRUCTION CANCELLOUS BONE SCREWS. THE PATIENT'S INDEX SURGERY OCCURRED ON (B)(6) 2023. ALL IMPLANTED DEVICES WERE EXPLANTED ON (B)(6) 2024. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE. THIS REPORT CAPTURES ONE MY3D PERSONALIZED PELVIC RECONSTRUCTION CANCELLOUS BONE SCREW.
Patient problems: Unspecified Infection
MAUDE report 19522206 ↗InjuryJun 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A PATIENT HAD AN ALLEGED INFECTION AND ELECTED TO HAVE AN AMPUTATION. THIS PATIENT WAS IMPLANTED WITH A MY3D PERSONALIZED SOLUTIONS PELVIS IMPLANT AND 10 MY3D PERSONALIZED PELVIC RECONSTRUCTION CANCELLOUS BONE SCREWS. THE PATIENT'S INDEX SURGERY OCCURRED ON (B)(6) 2023. ALL IMPLANTED DEVICES WERE EXPLANTED ON (B)(6) 2024. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE. THIS REPORT CAPTURES ONE MY3D PERSONALIZED PELVIC RECONSTRUCTION CANCELLOUS BONE SCREW.
Patient problems: Unspecified Infection
MAUDE report 19522204 ↗InjuryJun 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A PATIENT HAD AN ALLEGED INFECTION AND ELECTED TO HAVE AN AMPUTATION. THIS PATIENT WAS IMPLANTED WITH A MY3D PERSONALIZED SOLUTIONS PELVIS IMPLANT AND 10 MY3D PERSONALIZED PELVIC RECONSTRUCTION CANCELLOUS BONE SCREWS. THE PATIENT'S INDEX SURGERY OCCURRED ON (B)(6) 2023. ALL IMPLANTED DEVICES WERE EXPLANTED ON (B)(6) 2024. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE. THIS REPORT CAPTURES ONE MY3D PERSONALIZED PELVIC RECONSTRUCTION CANCELLOUS BONE SCREW.
Patient problems: Unspecified Infection
MAUDE report 19522203 ↗InjuryJun 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A PATIENT HAD AN ALLEGED INFECTION AND ELECTED TO HAVE AN AMPUTATION. THIS PATIENT WAS IMPLANTED WITH A MY3D PERSONALIZED SOLUTIONS PELVIS IMPLANT AND 10 MY3D PERSONALIZED PELVIC RECONSTRUCTION CANCELLOUS BONE SCREWS. THE PATIENT'S INDEX SURGERY OCCURRED ON (B)(6) 2023. ALL IMPLANTED DEVICES WERE EXPLANTED ON (B)(6) 2024. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE. THIS REPORT CAPTURES ONE MY3D PERSONALIZED PELVIC RECONSTRUCTION CANCELLOUS BONE SCREW.
Patient problems: Unspecified Infection
MAUDE report 19522202 ↗InjuryJun 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A PATIENT HAD AN ALLEGED INFECTION AND ELECTED TO HAVE AN AMPUTATION. THIS PATIENT WAS IMPLANTED WITH A MY3D PERSONALIZED SOLUTIONS PELVIS IMPLANT AND 10 MY3D PERSONALIZED PELVIC RECONSTRUCTION CANCELLOUS BONE SCREWS. THE PATIENT'S INDEX SURGERY OCCURRED ON (B)(6) 2023. ALL IMPLANTED DEVICES WERE EXPLANTED ON (B)(6) 2024. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE. THIS REPORT CAPTURES ONE MY3D PERSONALIZED PELVIC RECONSTRUCTION CANCELLOUS BONE SCREW.
Patient problems: Unspecified Infection
MAUDE report 19522200 ↗
Other Onkos Surgical, Inc. products
All Onkos Surgical, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page