• 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 UCENTUM SCREW, POLYAXIAL, 6.5MM, LENGTH 55MM

  • 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 UCENTUM SCREW, POLYAXIAL, 6.5MM, LENGTH 55MM Back to Search Results
Model Number CS 3802-065-055
Device Problem Fracture (1260)
Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)
Event Date 12/18/2019
Event Type  Injury  
Event Description
Approximately 16 months post-op, x-rays revealed non-union. A revision surgery was done to remove all hardware and found one screw and one rod were broken. Report 1 of 2.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUCENTUM
Type of DeviceSCREW, POLYAXIAL, 6.5MM, LENGTH 55MM
Manufacturer (Section D)
ULRICH GMBH & CO. KG
buchbrunnenweg 12
ulm, 89081
GM 89081
MDR Report Key9591580
MDR Text Key179812016
Report Number3005823819-2020-00002
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 01/07/2020,01/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCS 3802-065-055
Device Catalogue NumberCS 3802-065-055
Device Lot NumberUD12544
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/18/2019
Event Location Hospital
Date Report to Manufacturer01/07/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/15/2020 Patient Sequence Number: 1
-
-