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U.S. Department of Health and Human Services

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

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STRYKER TRAUMA KIEL UNKNOWN T2 TIBIA NAIL IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Anemia (1706)
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 tibial nailing systems¿ which was released on 10/31/2005 and is associated with the t2 tibial 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 211 complaints were initiated retrospectively for different adverse events mentioned in the report. The 23 patients developed early post-operative complications within the first week (day 1 to day 8). This product inquiry addresses anemia.
 
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Brand NameUNKNOWN T2 TIBIA 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 Key7903376
MDR Text Key121562541
Report Number0009610622-2018-01131
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,Followup
Report Date 12/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2018
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 Received11/19/2020
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: 09/24/2018 Patient Sequence Number: 1
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