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 UCENTUM; CROSSLINK VARIABLE, XXS
  • 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; CROSSLINK VARIABLE, XXS Back to Search Results
Model Number CS 3810-00
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Codes Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Date of Event 01/04/2020
Type of Reportable Event Serious Injury
Event or Problem Description
A crosslink broke in surgery during final tightening.It was removed and replaced with no effect on the patient.
 
Event or Problem Description
A crosslink broke in surgery during final tightening.It was removed and replaced with no effect on the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UCENTUM
Common Device Name
CROSSLINK VARIABLE, XXS
Manufacturer (Section D)
ULRICH GMBH & CO. KG
buchbrunnenweg 12
ulm, 89081
GM  89081
MDR Report Key9678087
Report Number3005823819-2020-00005
Device Sequence Number2757178
Product Code NKB
UDI-Device Identifier04052536080854
UDI-Public4052536080854
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Importer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date (Section B) 02/06/2020
Report Date (Section F) 01/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model NumberCS 3810-00
Device Catalogue NumberCS 3810-00
Device Lot NumberWSA14727340
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/09/2020
Event Location Hospital
Date Report to Manufacturer01/10/2020
Initial Date Received by Manufacturer Not provided
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date02/06/2020
Supplement Report FDA Received Date04/16/2020
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 Age66 YR
-
-