• 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 KIDS FLEXIBLE 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 KIDS FLEXIBLE NAIL IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem Injury (2348)
Event Date 01/01/2012
Event Type  Injury  
Manufacturer Narrative
This complaint has been reported during a literature review performed by the post market surveillance group. No product identification is possible. Based on the investigation results, no definitive relation could be established between the product and the reported failure adverse consequence. The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information will be provided. If further relevant information becomes available, the investigation will be reevaluated and resubmitted accordingly. Device disposition unknown.
 
Event Description
The manufacturer became aware of a pmcf from (b)(6), united states. The title of this report is ¿a retrospective data collection of the treatment of upper and lower extremity fractures with the t2 kids flexible nailing system. ¿ which is associated with the stryker ¿t2 kids flexible nailing¿ system. Within that publication, post-operative complications/ adverse events were reported, which occurred from 2012 to 2017. It was not possible to ascertain specific patient & device details 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 9 complaints were initiated retrospectively for adverse events mentioned in the report. This product inquiry addresses hardware prominence that required surgery for nail shortening & reinserted. 3 out of 4 cases. The report states: ¿4/66 (6%) patients had hardware prominence that required surgery for nail shortening as the sole complication. [¿] [¿] so this was 4 nails identified ¿ all femur nails, no forearm ¿ that had the nail back out thru the skin, that had to be shortened and reinserted, but not removed b/c bone hadn¿t healed yet. ¿.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN T2 KIDS FLEXIBLE NAIL
Type of DeviceIMPLANT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
D-24232
Manufacturer Contact
kevin smith
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9998706
MDR Text Key193057905
Report Number0009610622-2020-00181
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 study
Reporter Occupation
Type of Report Initial
Report Date 04/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2020
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 Received03/30/2020
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: 04/24/2020 Patient Sequence Number: 1
-
-