• 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 UNK T2 RECON 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 UNK T2 RECON NAIL IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Positioning Problem (3009)
Patient Problem Non-union Bone Fracture (2369)
Event Date 01/01/2012
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided on a supplemental report. Device not available to stryker.
 
Event Description
The manufacturer became aware of a post market clinical follow-up (pmcf) from (b)(6). The title of this report is ¿a post market clinical follow-up (pmcf) of the treatment of femoral fractures with the t2 recon nailing¿ which was released in july 2018 and is associated with the t2 recon nailing system. Within that report, postoperative complications/ adverse events were reported, which occurred between 2012 and 2017. It was not possible to ascertain specific device or patient information from the article, 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 report, therefore 7 complaints were initiated retrospectively for different adverse events mentioned in the journal. This product inquiry addresses malunion. One out of 1 case. The pmcfr states: ¿the final patient in our series who experienced an adverse event was found to have a malunion after a transverse proximal third femoral diaphysis fracture. This individual eventually underwent repeat operation with exchange nailing and implantation of a stryker t2 greater trochanteric femoral nail utilizing internal compression. Approximately 2. 5 months after exchange nailing, the patient was found to have radiographs consistent with bony consolidation of three cortices. ¿.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNK T2 RECON 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
melissa guattery
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7723502
MDR Text Key115202126
Report Number0009610622-2018-00388
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 07/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_KIE
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 Received07/02/2018
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: 07/26/2018 Patient Sequence Number: 1
-
-