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U.S. Department of Health and Human Services

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

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STRYKER TRAUMA KIEL T2 FEMORAL NAIL IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Insufficient Information (3190)
Patient Problems Nerve Damage (1979); Numbness (2415)
Event Date 10/31/2005
Event Type  Injury  
Manufacturer Narrative
It was noted that the device is not available for evaluation. If additional information is received, it will be provided in a supplemental report upon completion of the investigation. Device disposition is unknown.
 
Event Description
The manufacturer became aware of a international post-market product surveillance from (b)(6). The title of this report is ¿international post-market product surveillance - t2¿ femoral nailing systems¿ which was released on 10/31/2005 and is associated with the t2¿ femoral nailing system. Within that report, intraoperative and post-operative complications/ adverse events were reported. It was not possible to ascertain specific device or patient information from the article, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 24 complaints were initiated retrospectively for different adverse events mentioned in the report. This product inquiry addresses nerve problems in the right thigh (distal lateral femoral area a sensation of numbness), 1 out of 1 case.
 
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Brand NameT2 FEMORAL 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 Key7914355
MDR Text Key121895449
Report Number0009610622-2018-01318
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 literature
Reporter Occupation
Type of Report Initial
Report Date 09/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_KIE
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 Received09/06/2018
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: 09/27/2018 Patient Sequence Number: 1
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