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U.S. Department of Health and Human Services

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

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STRYKER TRAUMA KIEL UNKNOWN T2 PROXIMAL HUMERAL NAIL IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Failure of Implant (1924)
Event Date 03/31/2021
Event Type  malfunction  
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.
 
Event Description
The manufacturer became aware of a pmcf conducted by bellvitge university hospital in spain. The title of this report is ¿retrospective data collection of the treatment of humeral fractures with the t2 proximal humeral nailing system (phn)¿ which is associated with the stryker ¿t2 proximal humeral nailing (phn)¿ system. This report includes research done on 96 patients from the period january 2011 to july 2019. It was not possible to ascertain specific device details or patient information from the report, or to match the events reported with previously reported complaints. Therefore, new complaints were initiated in the system for the post-operative complications mentioned in the report. This product inquiry addresses implant dislocation (protrusion of the nail at the proximal level).
 
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Brand NameUNKNOWN T2 PROXIMAL HUMERAL 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 Key11768855
MDR Text Key254635652
Report Number0009610622-2021-00493
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Reporter Occupation
Type of Report Initial
Report Date 05/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2021
Is this an Adverse Event Report? No
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 Received04/07/2021
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

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