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 MEDICAL USA SOLIDITY; CENTER PIECE, YELLOW, 13MM, HEIGHT 16-21.5MM
  • 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 MEDICAL USA SOLIDITY; CENTER PIECE, YELLOW, 13MM, HEIGHT 16-21.5MM Back to Search Results
Model Number UU041-01-1621
Device Problem Material Fragmentation (1261)
Patient Problem Failure of Implant (1924)
Event Date 03/11/2021
Event Type  malfunction  
Event Description
During initial surgery, the cage was implanted and the surgeon went to expand it, but turned the inserter the wrong direction.This caused the locking mechanism and gear teeth of the cage to break off.The cage and all parts were removed and replaced with a different cage.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SOLIDITY
Type of Device
CENTER PIECE, YELLOW, 13MM, HEIGHT 16-21.5MM
Manufacturer (Section D)
ULRICH MEDICAL USA
18221 edison ave.
chesterfield MO 63005
Manufacturer (Section G)
ULRICH GMBH & CO. KG
buchbrunnenweg 12
ulm, baden-wurttemberg 89081
GM   89081
Manufacturer Contact
louis milos
18221 edison ave.
chesterfield, MO 63005
6365190268
MDR Report Key11640683
MDR Text Key244916610
Report Number3005823819-2021-00008
Device Sequence Number1
Product Code MQP
UDI-Device Identifier00814386022286
UDI-Public00814386022286
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181921
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberUU041-01-1621
Device Catalogue NumberUU041-01-1621
Device Lot NumberU021967
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2021
Date Manufacturer Received03/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/11/2019
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) Required Intervention;
-
-