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U.S. Department of Health and Human Services

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

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STRYKER TRAUMA KIEL UNKNOWN T2 NAIL IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Loss of or Failure to Bond (1068)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 04/15/2017
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Disposition unknown.
 
Event Description
The manufacturer became aware of a study from medical university of vienna, austria. The study was published on july 2017. Within that publication, 11 cases involving t2 ankle arthrodesis nail, or t2 tibial nail were reported, which were found to be off-label. The study states: ¿the purpose of this study was to present a case series of patients undergoing various techniques of joint fusion after bone reconstruction and deformity correction as a salvage procedure. The study should help trauma surgeons making decisions in limb salvage and deformity correction in complex lower leg and foot injuries by presenting options and treatment strategies. ¿ it was not possible to ascertain specific device from the report; a review of the complaint handling database, however, revealed that the events have not been reported previously. Therefore 11 complaints were initiated retrospectively for the off-label use and subsequent adverse events mentioned in the report. This product inquiry addresses delayed union of arthrodesis. 2 out of 2 cases.
 
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Brand NameUNKNOWN T2 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 Key8105645
MDR Text Key128405327
Report Number0009610622-2018-01493
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 11/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2018
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 Received10/31/2018
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: 11/27/2018 Patient Sequence Number: 1
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