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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2 ALPHA GT NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL UNKNOWN T2 ALPHA GT NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number UNK_KIE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Impaired Healing (2378)
Event Date 12/13/2021
Event Type  Injury  
Event Description
The manufacturer became aware of a pmcf final study report that was conducted by university of (b)(6) in the usa. The title of this report is ¿a retrospective data collection of the treatment of femoral fractures with the femoral nail greater trochanter (gt) of the t2 alpha femur antegrade gt/pf nailing system¿, which is associated with the stryker ¿t2 alpha femur antegrade gt/pf nailing¿ system. This report includes analysis of the clinical data that was collected on 9 patients, the cases in this study range from march 2019 through july 2020. During the review of the literature, it was not possible to establish a specific device details, patient information, and at this time no additional device information is available. It was reported that one patient experienced delayed healing. The report states: ¿delayed healing: (b)(6) female, bmi (b)(6) with a history of osteoporotic sub trochanteric 32-a3 closed fracture in her left femur and an impending fracture in her right femur. Both femurs were treated with t2 alpha gt nails. Her left femur fracture resulted in delayed healing 432 days post-op and her right impending fracture resulted in healing 180 days post-op. Therefore, this is probably a non-device related adverse event. ¿.
 
Manufacturer Narrative
This complaint has been generated based on findings discovered during post market surveillance pmcf study review. The alleged delayed healing included in the study could not be confirmed, since the device was not returned for evaluation and no other additional information will be made available. 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. Device disposition is unknown.
 
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Brand NameUNKNOWN T2 ALPHA GT 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 Key13266100
MDR Text Key285615531
Report Number0009610622-2022-00019
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study
Reporter Occupation
Type of Report Initial
Report Date 01/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2022
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 Received12/19/2021
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: 01/17/2022 Patient Sequence Number: 1
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