• 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 UNKNOWN T2 ANKLE ARTHRODESIS NAIL IMPLANT

  • 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 UNKNOWN T2 ANKLE ARTHRODESIS NAIL IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cellulitis (1768)
Event Date 07/01/2011
Event Type  Injury  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report. Device evaluated by mfr: device disposition unknown.
 
Event Description
The manufacturer became aware of a study from southmead hospital united kingdom. The title of this study is ¿tibiotalocalcaneal nail fixation and soft tissue coverage of gustilo¿anderson grade 3b open unstable ankle fractures in a frail population; a case series in a major trauma centre¿ and is associated with the t2 ankle arthrodesis nail. Within that publication, post-operative complications/ adverse events were reported, which occurred between 1 july 2011 and 30 june 2016. It was not possible to ascertain specific device catalogs from the report; a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication. Therefore, 10 complaints were initiated retrospectively for different adverse events mentioned in the report. This product inquiry addresses cellulitis. The study states that: ¿one patient developed cellulitis over the flap¿this was successfully treated with antibiotics. ¿.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN T2 ANKLE ARTHRODESIS NAIL
Type of DeviceIMPLANT
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
rose haas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8506407
MDR Text Key141730820
Report Number0009610622-2019-00157
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGB
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 04/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_KIE
Device Lot NumberUNKNOWN
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 Received04/01/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 04/11/2019 Patient Sequence Number: 1
-
-