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: ULRICH GMBH & CO. KG NEON3; NEON SCREW, SELF-TAPPING, CANNULATED, 4.0MM LENGTH 30MM
  • 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
 

ULRICH GMBH & CO. KG NEON3; NEON SCREW, SELF-TAPPING, CANNULATED, 4.0MM LENGTH 30MM Back to Search Results
Model Number CS 1401-30T
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 11/25/2021
Type of Reportable Event Serious Injury
Event or Problem Description
Initial surgery (b)(6) 2020, complete instrumentation can be seen in the image made during the surgery.After the surgery patient had a good recovery.According to patient, restrictions were followed.On (b)(6) 2021, a fracture in neon was detected in mr.Patient is well, waiting to know the next steps.Report 1 of 2.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NEON3
Common Device Name
NEON SCREW, SELF-TAPPING, CANNULATED, 4.0MM LENGTH 30MM
Manufacturer (Section D)
ULRICH GMBH & CO. KG
buchbrunnenweg 12
ulm, baden-wurttemberg 89081
GM  89081
MDR Report Key12984415
Report Number3005823819-2021-00031
Device Sequence Number5565223
Product Code NKG
UDI-Device Identifier04052536002863
UDI-Public04052536002863
Combination Product (Y/N)N
Initial Reporter CountryBR
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/10/2021
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
Device Model NumberCS 1401-30T
Device Catalogue NumberCS 1401-30T
Device Lot NumberWSA12651810
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/06/2021
Device Age16 YR
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date12/13/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization;
Patient SexUnknown
-
-