FDA Adverse Event
Injury
Summary report: N
VSP ORTHOPAEDICS
MDR report key: 13696983
·
Received March 8, 2022
Report
- Report Number
- 1724955-2022-00003
- Event Type
- Injury
- Date Received
- March 8, 2022
- Date of Event
- February 15, 2022
- Report Date
- February 24, 2022
- Manufacturer
- 3D SYSTEMS
- Product Code
- PBF
- UDI-DI
- 00816847022453
- PMA / PMN Number
- K190044
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
3D SYSTEMS INVESTIGATION IS ONGOING, NO ROOT CAUSE HAS BEEN DETERMINED AT THIS TIME. SURGERY WAS SUCCESSFUL AND NO ADVERSE EVENTS WERE REPORTED.
Description of Event or Problem · 0
DURING A VSP ORTHOPAEDICS TIBIA RESECTION AND ALLOGRAFT RECONSTRUCTION PROCEDURE, THE GUIDES PROVIDED BY 3D SYSTEMS DID NOT PRODUCE AN ACCURATE REPRESENTATION OF THE PLANNED ALLOGRAFT USED IN SURGERY. THE SURGEON NOTED THAT THE PHYSICAL ALLOGRAFT AND THE ALLOGRAFT MODEL WERE MIRRORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2632053 | VSP ORTHOPAEDICS | TIBIA ALLOGRAFT CUTTING GUIDE | PBF | 3D SYSTEMS | Allograft Orthopedic Model | 162603 | 00816847022453 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Female | Other |