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

Model Number	Allograft Tibia Cutting Guide
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
For a vsp orthopedics tibia resection and allograft reconstruction procedure, the surgeon noted the following issues: the allograft tibia cutting guide did not fit the allograft.The patient's native remaining bony anatomy at the proximal end of the tibia fractured during the cutting process using the patient tibia cutting guide.Investigation at this time revealed no root cause attributed to 3d systems for the above issues.No additional surgical intervention was required.An incorrect revision of the case report was provided to the surgeon.This was identified and corrected prior to surgery.
Event or Problem Description
For a vsp orthopedics tibia resection and allograft reconstruction procedure, the surgeon noted the following issues: the allograft tibia cutting guide did not fit the allograft.The patient's native remaining bony anatomy at the proximal end of the tibia fractured during the cutting process using the patient tibia cutting guide.Investigation at this time revealed no root cause attributed to 3d systems for the above issues.No additional surgical intervention was required.An incorrect revision of the case report was provided to the surgeon.This was identified and corrected prior to surgery.

• Brand Name: VSP ORTHOPEDICS
• Common Device Name: ALLOGRAFT TIBIA CUTTING GUIDE
• Manufacturer (Section D): 3D SYSTEMS; 5381 south alkire circle; littleton CO 80127
• MDR Report Key: 10518178
• Report Number: 1724955-2020-00004
• Device Sequence Number: 3575530
• Product Code: PBF
• UDI-Device Identifier: 00816847021845
• UDI-Public: (01)00816847021845(10)136033
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/09/2020

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: 01/21/2021
• Device Model Number: Allograft Tibia Cutting Guide
• Device Lot Number: 136033
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 09/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 41 YR