• 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 FEMORAL 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 FEMORAL NAIL IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Separation Problem (4043)
Patient Problems Ossification (1428); Failure of Implant (1924)
Event Date 09/15/2020
Event Type  Injury  
Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available. More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event. The device history record could not be reviewed because the affected lot number was not communicated. If any further information is provided, the investigation report will be updated. Device disposition is unknown.
 
Event Description
The manufacturer became aware of a post market clinical follow-up report received from (b)(6) medical center, in usa. The title of this report is ¿a retrospective data collection of the treatment of femur fractures with the t2 femoral nailing system¿ which is associated with the stryker ¿t2 femoral nailing system¿. This study includes research done on 52 patients requiring surgery between the period february 15, 2017 to september 1, 2019. It was not possible to ascertain specific device details from the report, or to match the events reported with previously reported complaints. Therefore, new complaint was initiated in the system for the post-operative complication mentioned in the report. This product inquiry addresses heterotopic bone on the lateral femur and interlocking screw back out for which heterotopic bone excision and screw removal was performed. The report states: ¿patient (b)(6) sustained a closed fracture of their left femur due to an atv accident. At 7 months postoperatively, the patient was identified as having developed heterotopic bone on the lateral femur as well as a failed interlocking screw (i. E. Backed out). The patient then returned to the operating room for heterotopic bone excision and screw removal. The revision was complicated with an infection of the knee and gastrocnemius muscle; to which rod removal was recommended. The infection was not considered an adverse event since it was not a complication of the primary surgery. The patient was lost to follow up prior to rod removal. ¿.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN T2 FEMORAL NAIL
Type of DeviceIMPLANT
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 Key10737557
MDR Text Key213173378
Report Number0009610622-2020-00591
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 10/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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 Received09/29/2020
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: 10/26/2020 Patient Sequence Number: 1
-
-