MAUDE Adverse Event Report: 3D SYSTEMS VSP SYSTEM; SURGICAL GUIDE

Model Number	Sagittal Split Marking Guide
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Stryker facial id plating system (k193143) customized plates did not align with 3d systems guides (lefort marking guide, maxilla cutting guide, and sagittal split marking guide).This issue was identified during surgery after the surgeon had used the guides to fixate custom plates in the patient's maxilla and mandible.Upon identification, the plates were removed and new holes were drilled for fixation.The issue caused unnecessary holes to be drilled into the patient , however, the surgery was successful with no adverse effects to the patient.The issue added 90 additional minutes to the procedure.Investigation identified case planning files were incorrectly exported by 3d systems personnel resulting in the 3d systems guides to incorrectly indicate the custom plate fixation hole location for the surgical procedure.

• Brand Name: VSP SYSTEM
• Common Device Name: SURGICAL GUIDE
• Manufacturer (Section D): 3D SYSTEMS; 5381 south alkire circle; littleton CO 80127
• MDR Report Key: 11037135
• Report Number: 1724955-2020-00006
• Device Sequence Number: 19088499
• Product Code: DZJ
• UDI-Device Identifier: 00816847020633
• UDI-Public: (01)00816847020633(10)141324
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K192192
• 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): 12/17/2020

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 Model Number: Sagittal Split Marking Guide
• Device Lot Number: 141324
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 12/18/2020
• 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: 19 YR