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U.S. Department of Health and Human Services

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

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STRYKER TRAUMA KIEL UNKNOWN T2 ANTEGRADE INTERLOCKING NAIL IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problems Migration (4003); Separation Problem (4043)
Patient Problems Failure of Implant (1924); Pain (1994); Injury (2348)
Event Date 04/05/2011
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 study from general hospital of (b)(6). The title of this report is ¿treatment of humeral shaft fractures with antegrade intramedullary locking nail¿ which is associated with the stryker ¿t2 locking nail¿ system. Within that publication, post-operative complications/ adverse events were reported, which published on 05 april 2011. It was not possible to ascertain specific device/patient details from the report, 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 6 complaints was initiated retrospectively for adverse events mentioned in the report and the pubmed id for the literature is 21744026. This product inquiry addresses proximal locking screw backout followed by its removal. 2 out of 2 cases. The report states: ¿in two patients, over 60 years old, two proximal locking screws backed out and caused shoulder pain and removed under local anesthesia. ¿.
 
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Brand NameUNKNOWN T2 ANTEGRADE INTERLOCKING NAIL
Type of DeviceIMPLANT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
D-24232
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10104924
MDR Text Key195239537
Report Number0009610622-2020-00272
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2020
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 Received08/22/2020
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: 06/01/2020 Patient Sequence Number: 1
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