• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL U-BLADE SET, TI GAMMA3 10.5X95MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

  • 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
 

STRYKER TRAUMA KIEL U-BLADE SET, TI GAMMA3 10.5X95MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 3066-0095S
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Patient Problems Perforation (2001); Hip Fracture (2349)
Event Date 01/29/2021
Event Type  Injury  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
As reported: "after tha surgery (right side), cutout of a lag screw occurred at the femoral head. After that, the lag screw invaded the pelvis. The initial surgery performed on (b)(6) 2021, the event was confirmed on (b)(6) 2021. The re-operation was performed on (b)(6) 2021. Additional information received on 17-feb-202: "at the time of the initial operation, the operation was completed without inserting the u blade of the u lag screw and the end cap for the lag screw. In addition, it has been confirmed that the lag screw did not turn when the set screw was not loosened in the removal process. So, the surgeon recognized that the set screw was fixed to some extent. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameU-BLADE SET, TI GAMMA3 10.5X95MM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer Contact
marilyne chaumont
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key11417551
MDR Text Key239567312
Report Number0009610622-2021-00326
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K043431
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number3066-0095S
Device Catalogue Number30660095S
Device Lot NumberK078223
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/23/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/04/2021 Patient Sequence Number: 1
-
-