MAUDE Adverse Event Report: 3D SYSTEMS HEALTHCARE VSP SYSTEM; INTERMEDIATE SURGICAL SPLINT

Catalog Number VSPO-302

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2021

Event Type  Injury  

Manufacturer Narrative

The surgeon was able to manipulate the splint to achieve the patient's final occlusion without any significant surgical delay.Upon further investigation from the surgeon and 3ds, it was determined that the intermediate splints were designed off a deviated version of the digital files of the patient's maxilla.No adverse effects were reported after surgery.

Event Description

The surgeon reported that the vsp system intermediate surgical splint did not fit the surgeon's planned intermediate position of the patient's mandible for a double jaw orthognathic surgery.

• Brand Name: VSP SYSTEM
• Type of Device: INTERMEDIATE SURGICAL SPLINT
• Manufacturer (Section D): 3D SYSTEMS HEALTHCARE; 5381 south alkire circle; littleton CO 80127
• Manufacturer (Section G): 3D SYSTEMS HEALTHCARE; 5381 south alkire circle; littleton CO 80127
• Manufacturer Contact: ben johnson ; 5381 south alkire circle; littleton, CO 80127 ; 7206431001
• MDR Report Key: 12820797
• MDR Text Key: 280827247
• Report Number: 1724955-2021-00006
• Device Sequence Number: 1
• Product Code: DZJ
• UDI-Device Identifier: 0081684720534
• UDI-Public: (01)0081684720534(10)157096
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120956
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VSPO-302
• Device Lot Number: 157096
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2021
• 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 Age: 37 YR
• Patient Sex: Female