• 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 TIBIAL NAIL T2 ALPHA? TIBIA Ø10X375MM 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 TIBIAL NAIL T2 ALPHA? TIBIA Ø10X375MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 2341-1037S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Discomfort (2330); Non-union Bone Fracture (2369); Implant Pain (4561)
Event Date 05/04/2022
Event Type  Injury  
Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed. Should additional information become available, it will be provided in a supplemental report. Device disposition unknown.
 
Event Description
As reported: "the patient is a (b)(6) male who previously underwent debridement and intramedullary fixation for an open tibial shaft fracture distally. The patient has been watched closely over the course of the past year. He did perform some healing callus around the fracture site, however, had some persistent pain. A ct scan revealed that there was a persistent fracture lucency consistent with nonunion. The patient was having discomfort. The patient was recommended treatment to include removal of his hardware and exchange nailing to a larger diameter nail with local reamed autograft. Resolved with sequelae: date of resolution (b)(6) 2022".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTIBIAL NAIL T2 ALPHA? TIBIA Ø10X375MM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key15070796
MDR Text Key296287648
Report Number0009610622-2022-00332
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07613327291186
UDI-Public07613327291186
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191271
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number2341-1037S
Device Catalogue Number23411037S
Device Lot NumberD10XL375
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/23/2022
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: 07/20/2022 Patient Sequence Number: 1
-
-