Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3D SYSTEMS HEALTHCARE VSP SYSTEMS; MANDIBLE CUTTING GUIDE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

3D SYSTEMS HEALTHCARE VSP SYSTEMS; MANDIBLE CUTTING GUIDE Back to Search Results
Catalog Number VSPO-550
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/30/2024
Event Type  Injury  
Event Description
A surgeon reported that following the use of a vsp systems cutting guide, the holes on the patient's left distal mandible were too low to be used with the custom plate.As a result, the surgeon drilled additional holes to allow for proper alignment.No surgical delay was reported, and the surgery was completed successfully.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VSP SYSTEMS
Type of Device
MANDIBLE CUTTING GUIDE
Manufacturer (Section D)
3D SYSTEMS HEALTHCARE
5381 s alkire st
littleton CO 80127
Manufacturer (Section G)
3D SYSTEMS HEALTHCARE
5381 s alkire st
littleton CO 80127
Manufacturer Contact
ben johnson
5381 s alkire st
littleton, CO 80127
7206431011
MDR Report Key18822827
MDR Text Key336732389
Report Number1724955-2024-00001
Device Sequence Number1
Product Code DZJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192192
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberVSPO-550
Was Device Available for Evaluation? No
Date Manufacturer Received02/02/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/17/2024
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age36 YR
Patient SexMale
-
-