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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2SCN NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL UNKNOWN T2SCN NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number UNK_KIE
Device Problems Break (1069); Fracture (1260)
Patient Problem Insufficient Information (4580)
Event Date 07/01/2015
Event Type  Injury  
Manufacturer Narrative
This complaint has been generated based on findings discovered during post market surveillance literature review. The alleged 1 patient that experienced proximal tibial fragility fracture 2 months after surgery as mentioned in the literature could not be confirmed, since the device was not returned for evaluation and no other additional information was received from the author. More detailed information about the patient medical history, the event circumstances, radiographs and the involved device(s) must be available in order to determine the root cause. If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.
 
Event Description
The manufacturer became aware of a literature published by department of orthopaedic surgery, saiseikai senri hospital, japan. The title of this report is ¿treatment of distal femoral fractures using retrograde femoral nails in elderly patients¿ published on july 1 2015, which is associated with the stryker t2scn system. The article can be found at https://doi. Org/10. 11359/chubu. 2012. 1409. This report includes analysis of the clinical data that was collected on 57 patients, the cases in this study range from april 2009 and october 2014. During the review of the literature, it was not possible to establish specific device details, patient information, and at this time no additional device information is available. It was reported that 1 patient experienced proximal tibial fragility fracture 2 months after surgery.
 
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Brand NameUNKNOWN T2SCN NAIL
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key13690838
MDR Text Key288356684
Report Number0009610622-2022-00079
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial
Report Date 03/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2022
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
Date Manufacturer Received02/09/2022
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: 03/08/2022 Patient Sequence Number: 1
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