Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 SUPRACONDYLAR NAIL T2 SCN Ø13X400MM; 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 SUPRACONDYLAR NAIL T2 SCN Ø13X400MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18261340S
Health Effect - Clinical Code Fall (1848)
Date of Event 01/08/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.
 
Event or Problem Description
This pi is for the revision of the t2 nail.While reporting a revision of patient's left knee, rep reported that after patient had knee implanted, patient fell and sustained a femoral fracture.A t2 nail was implanted to address the fracture and was later removed at an unknown date for an unknown reason.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SUPRACONDYLAR NAIL T2 SCN Ø13X400MM
Common Device Name
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
MDR Report Key8304870
Report Number0009610622-2019-00064
Device Sequence Number1619604
Product Code HSB
UDI-Device Identifier04546540379290
UDI-Public04546540379290
Combination Product (Y/N)N
Initial Reporter StateNH
Initial Reporter CountryUS
PMA/510(K) Number
K023267
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2018
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date09/30/2020
Device Catalogue Number18261340S
Device Lot NumberK0C1705
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/08/2019
Initial Report FDA Received Date02/05/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age60 YR
-
-