• 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® Ø10.5X95MM 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® Ø10.5X95MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 30660095S
Device Problem Migration (4003)
Patient Problems Fall (1848); Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544)
Event Date 10/18/2018
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device was discarded.
 
Event Description
Cut out of u lag screw occurs. Patient felt pain on his hip for several weeks and difficult to walk. Then, when falling on 18th, visited in the hospital and an x - ray film was taken, it turned out that the lag screw had cut out and reached the acetabular. There is no dislocation of the pieces of the bony skull, and only the lag screw has cut out. As a measure after occurrence, on 12th october replaced 120 ° gamma nail.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameU-BLADE SET, TI GAMMA3® Ø10.5X95MM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8074990
MDR Text Key127341368
Report Number0009610622-2018-01381
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
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 12/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number30660095S
Device Lot NumberK0EB4B4
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/29/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/18/2018
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: 11/15/2018 Patient Sequence Number: 1
-
-