MAUDE Adverse Event Report: 3D SYSTEMS VSP ORTHOPAEDICS; TIBIA ALLOGRAFT CUTTING GUIDE

Model Number	Allograft Orthopedic Model
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
3d systems investigation is ongoing, no root cause has been determined at this time.Surgery was successful and no adverse events were reported.
Event or Problem Description
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.

• Brand Name: VSP ORTHOPAEDICS
• Common Device Name: TIBIA ALLOGRAFT CUTTING GUIDE
• Manufacturer (Section D): 3D SYSTEMS; 5381 south alkire circle; littleton CO 80127
• Manufacturer (Section G): 3D SYSTEMS; 5381 south alkire circle; littleton CO 80127
• Manufacturer Contact: ben johnson ; 5381 south alkire circle; littleton, CO 80127 ; 7206431001
• MDR Report Key: 13696983
• Report Number: 1724955-2022-00003
• Device Sequence Number: 6362669
• Product Code: PBF
• UDI-Device Identifier: 00816847022453
• UDI-Public: (01)00816847022453(10)162603
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K190044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2022
• Device Model Number: Allograft Orthopedic Model
• Device Catalogue Number: VSP-OP-301
• Device Lot Number: 162603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 26 YR
• Patient Sex: Female