MAUDE Adverse Event Report: 3D SYSTEMS HEALTHCARE VSP SYSTEM; CRANIAL POSITIONING GUIDE

Model Number	Cranial Positioning Guide
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During a cranial vault procedure utilizing virtual surgical planning, a surgical cranial positioning guide appeared to be too small to fit the bone segments created utilizing a corresponding surgical marking guide.The surgeon opted to not utilize the cranial positioning guide and as a result, reported a 2 hour delay in surgery.
Additional Manufacturer Narrative
A review of the design files for the marking and positioning guides, showed the guides were designed correctly to the specifications and surgical plan performed by the surgeon.3d systems requested the marking and positioning guide be returned for additional testing.The returned guides were retrofitted with 3d printed representations of the bone segments from the planned surgical procedure.The 3d printed bone segments correctly fit both the returned marking guide and positioning guides.

• Brand Name: VSP SYSTEM
• Common Device Name: CRANIAL POSITIONING GUIDE
• Manufacturer (Section D): 3D SYSTEMS HEALTHCARE; 5381 s alkire circle; littleton CO 80127
• Manufacturer (Section G): 3D SYSTEMS HEALTHCARE; 5381 s alkire circle; littleton CO 80127
• Manufacturer Contact: ben johnson ; 5381 s alkire circle; littleton, CO 80127
• MDR Report Key: 15491849
• Report Number: 1724955-2022-00013
• Device Sequence Number: 16633735
• Product Code: DZJ
• UDI-Device Identifier: 00816847021425
• UDI-Public: (01)00816847021425(10)
• 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
• Type of Report: Initial
• Report Date (Section B): 08/30/2022

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 Model Number: Cranial Positioning Guide
• Device Catalogue Number: VSPR-310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2022
• 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: 11 MO
• Patient Sex: Female