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U.S. Department of Health and Human Services

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

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STRYKER TRAUMA KIEL UNKNOWN T2 ALPHA TIBIA NAIL IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Separation Problem (4043)
Patient Problem Failure of Implant (1924)
Event Date 10/21/2020
Event Type  Injury  
Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available. More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event. The device history record could not be reviewed because the affected lot number was not communicated. If any further information is provided, the investigation report will be updated. Device disposition is unknown.
 
Event Description
The manufacturer became aware of a post market clinical follow-up report received from mount sinai hospital, in united states. The title of this report is ¿a retrospective data collection of the treatment of tibia fractures with the t2 alpha tibia nailing system¿ which is associated with the stryker ¿t2 alpha tibia nailing system¿. This study includes research done on 28 patients requiring surgery between the period january 2019 and october 2019. It was not possible to ascertain specific device details from the report, or to match the events reported with previously reported complaints. Therefore, new complaint was initiated in the system for the post-operative complication mentioned in the report. This product inquiry addresses screw loosening for which revision surgery was performed to correct the implant. The report states: ¿only 1 patient experienced a post-operative adverse event, described in the table below as ¿screw loosening¿. This complication occurred 75 days after surgery and the patient had revision surgery to correct the implant. Patient was not permanently disabled and patient did not die. [¿] her initial indication for surgery was non-union and malunion. ¿.
 
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Brand NameUNKNOWN T2 ALPHA 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
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10888928
MDR Text Key218511792
Report Number0009610622-2020-00762
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 11/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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 Received10/28/2020
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: 11/23/2020 Patient Sequence Number: 1
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