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U.S. Department of Health and Human Services

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

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STRYKER TRAUMA KIEL UNKNOWN T2 ANKLE ARTHRODESIS NAIL IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Loss of or Failure to Bond (1068)
Patient Problem Impaired Healing (2378)
Event Date 05/01/2009
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided on a supplemental report. Device disposition unknown.
 
Event Description
The manufacturer became aware of a study from department of orthopaedics, ipswich general hospital, ipswich, australia which was published in september 2015. The title of this study is ¿retrograde intramedullary tibiotalocalcaneal (hindfoot) arthrodesis with concomitant midfoot and forefoot corrections¿ and is associated with the stryker t2 ankle arthrodesis nailing system. Within that publication, post-operative complications/ adverse events were reported, which occurred between may 2009 and may 2013. It was not possible to ascertain specific device details from the report, a review of the complaint handling database, however, revealed that the event has not been reported by the hospital or by the author of the publication, therefore 10 complaint was initiated retrospectively for the different adverse event mentioned in the report. This product inquiry addresses nonunion. 1 out of 3 cases. The study states that, "of our patients that have nonunion (3 patients, 5%), all are diabetic with charcot arthropathy affecting the hindfoot and aged 53, 63, and 73 years. The tibiotalar joint failed to fuse in all 3 instances. However, successful limb salvage has been achieved through ongoing customized, immobilizing footwear. Outcomes: psuedoarthrosis, pain free, weight-bearing. ¿.
 
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Brand NameUNKNOWN T2 ANKLE ARTHRODESIS NAIL
Type of DeviceIMPLANT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer Contact
rose haas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8544203
MDR Text Key143244413
Report Number0009610622-2019-00221
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 04/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2019
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 Received04/15/2019
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: 04/24/2019 Patient Sequence Number: 1
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