• 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 LAG SCREW CASE 1 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 LAG SCREW CASE 1 IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Limb Fracture (4518); Unequal Limb Length (4534); Implant Pain (4561)
Event Date 10/30/2014
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 literature published by department of traumatic orthopedics, tianjin hospital, china. The title of this report is ¿analysis of complications of intertrochanteric fracture treated with gamma 3 intramedullary nail¿ published on october 30, 2014, which is associated with the stryker ¿gamma3 nailing¿ system. The article can be found at issn:1940-5901/ijcem0001817. This report includes research done on 186 patients and data collection period not mentioned in the literature. It was not possible to ascertain specific device details or patient information from the report, or to match the events reported with previously reported complaints. Therefore, new complaints were initiated in the system for the post-operative complications mentioned in the report. This product inquiry addresses 3 cases of cut-out of lag screws. The report states: "cut-out of lag screws occurred in 3 cases. The time in bed of patients was prolonged in the cases of refracture of femur shaft during the gamma 3 nail inserting into the medullary cavity, fractures with a gap or malalignment in closed reduction of a3 type, postoperatively fracture re-displacement and cut-out of lag screws. They achieved union for a maximum of 4 months. In one case of cut-out of lag screw, the lag screw affected the hip joint activity and the patient felt pain 5 months after surgery. The internal fixation was removed ten months after surgery and the affected limb was 3 cm shortened than the well one. ¿ ¿the causes of cut-out include non-anatomical reduction of fractures, lag screw placement not ideal, complex fracture type and design of internal fixation devices. ¿.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN LAG SCREW CASE 1
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
kristen canter
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12611015
MDR Text Key275875971
Report Number0009610622-2021-00751
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 10/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2021
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 Received09/17/2021
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: 10/11/2021 Patient Sequence Number: 1
-
-