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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2 KNEE ARTHRODESIS NAIL IMPLANT

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STRYKER TRAUMA KIEL UNKNOWN T2 KNEE ARTHRODESIS NAIL IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Separation Problem (4043)
Patient Problems Failure of Implant (1924); Implant Pain (4561)
Event Date 09/15/2020
Event Type  Injury  
Manufacturer Narrative
This complaint has been reported during a literature review performed by the post market surveillance group. No product identification is possible. Based on the investigation results, no definitive relation could be established between the product and the reported failure adverse consequence. The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information will be provided. If further relevant information becomes available, the investigation will be reevaluated and resubmitted accordingly.
 
Event Description
The manufacturer became aware of a post market clinical follow-up report received from university of cincinnati medical center, in usa. The title of this report is ¿a retrospective data collection of the treatment of long bone fractures with the t2 knee arthrodesis nailing system (t2 kan)¿ which is associated with the stryker ¿t2 knee arthrodesis nailing system¿. This study includes research done on 4 patients requiring surgery between the period january 1, 2013 to december 31, 2018. 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 distal locking screw loosening, pain and irritation at the screw site for which hardware was removed 10. 5 months postoperatively. The report states: ¿patient one is a 57-year-old female who had a left knee arthrodesis performed. They had a distal locking screw become loose and prominent and has dealt with pain and irritation at the screw site. Therefore, after discussing risks, benefits and alternatives of treatment, they elected to undergo surgical removal of hardware at 10. 5 months postoperatively. Culture and biopsy were negative for infection or pathologic bone. ¿.
 
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Brand NameUNKNOWN T2 KNEE ARTHRODESIS 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
marilyne chaumont
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10726398
MDR Text Key212793842
Report Number0009610622-2020-00576
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,Followup
Report Date 12/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2020
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 Received11/10/2020
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: 10/23/2020 Patient Sequence Number: 1
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