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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN DISTAL LOCKING SCREW 1 IMPLANT

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STRYKER TRAUMA KIEL UNKNOWN DISTAL LOCKING SCREW 1 IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Thrombosis/Thrombus (4440); Swelling/ Edema (4577)
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.
 
Event Description
The manufacturer became aware of a post market clinical follow-up report received from (b)(6), 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 significant leg swelling and deep vein thrombosis for which patient was placed on anticoagulation. The report states, ¿patient ten, after undergoing intramedullary rodding of the left femur, presented 6-weeks postoperatively with significant leg swelling and was diagnosed with deep vein thrombosis. They were then placed on anticoagulation. The thrombosis has since been resolved. ¿.
 
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Brand NameUNKNOWN DISTAL LOCKING SCREW 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
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10737542
MDR Text Key216113225
Report Number0009610622-2020-00592
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? 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 Received09/29/2020
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
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