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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Numbness (2415)
Event Date 01/01/2006
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 (b)(6), which was published on 10 september 2009. The title of this study is ¿the use of a retrograde fixed-angle intramedullary nail for tibiocalcaneal arthrodesis after severe loss of the talus¿ and is associated with the stryker t2 ankle arthrodesis nailing system. Within that publication, post-operative complications/ adverse events were reported, which occurred between 2006 and 2007. 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 3 complaints were initiated retrospectively for the different adverse event mentioned in the report. This product inquiry addresses infection. The study states: ¿one patient (patient 6), despite negative intra-operative microbiologic cultures, had a recurrence of infection. This patient had total loss of his talus following repeated surgery and had undergone screw fixation of the tibionavicular and the calcaneocuboid sites additionally, and a peroneus brevis flap. With recurrence of infection, the fixation implants were removed at 1 year post-fusion, and the sinus tract excised and the wound debrided. At that time the fusion site had healed. Five episodes of debridement were needed to obtain a clean wound and the defect was covered with a split-skin graft. There was no evidence of recurrence of infection subsequently, but this patient had numbness of the toes and recurrent metatarsalgia on prolonged 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 Key8547121
MDR Text Key143050024
Report Number0009610622-2019-00223
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
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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