MAUDE Adverse Event Report: 3D SYSTEMS COMPASSIONATE USE DEVICE; TIBIA CUTTING GUIDE

Lot Number 135765

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Osteomyelitis (4533)

Event Date 09/21/2020

Event Type  Injury  

Manufacturer Narrative

The patient's tibia became infected after the allograft reconstruction procedure and a surgical intervention to remove the patient's allograft was successful.3d systems provided a compassionate use device patient tibia cutting guide and a compassionate use device allograft tibia cutting guide for the initial procedure (tumor resection and allograft reconstruction) through the fda expanded access pathway (u200183).Upon investigation, there were no identified failure modes in the design or manufacturing of the device, nor any reported malfunctions of device during its use.All instructions provided in the ifu were stated to be followed prior to and during the use of the device.The patient will undergo additional surgery at a later date to implant a new allograft tibia.

Event Description

The patient's tibia became infected after the allograft reconstruction procedure and a surgical intervention to remove the patient's allograft was successful.3d systems provided a compassionate use device patient tibia cutting guide and a compassionate use device allograft tibia cutting guide for the initial procedure (tumor resection and allograft reconstruction) through the fda expanded access pathway (u200183).Upon investigation, there were no identified failure modes in the design or manufacturing of the device, nor any reported malfunctions of device during its use.All instructions provided in the ifu were stated to be followed prior to and during the use of the device.The patient will undergo additional surgery at a later date to implant a new allograft tibia.

• Brand Name: COMPASSIONATE USE DEVICE
• Type of Device: TIBIA 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: scott brewer ; 5381 south alkire circle; littleton, CO 80127 ; 7206431001
• MDR Report Key: 10825217
• MDR Text Key: 215907480
• Report Number: 1724955-2020-00005
• Device Sequence Number: 1
• Product Code: PBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: U200183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 135765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR