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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL PROXIMAL SCREW IMPLANT

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STRYKER TRAUMA KIEL PROXIMAL SCREW IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Material Protrusion/Extrusion (2979)
Patient Problems Irritation (1941); Pain (1994); Therapeutic Response, Decreased (2271)
Event Date 01/01/2012
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device disposition unknown.
 
Event Description
The manufacturer became aware of a 'retrospective data collection report' from (b)(6). The title of this study is ¿a retrospective data collection of the treatment of humeral fractures with the t2 proximal humeral nailing system (phn)¿ and is associated with the t2 proximal humeral nailing system (phn). Within that publication, post-operative complications/ adverse events were reported, which occurred between 2012 to 2017. It was not possible to ascertain specific device catalogs 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 30 complaints were initiated retrospectively for different adverse events mentioned in the report. This product inquiry addresses lag screw protrusion (cut out); 5 out of 13 cases. The report states, "a (b)(6) caucasian female (#41) suffered two adverse events. She showed functional deficit due to a prominent proximal screw. The screw was removed 86 days after surgery. 6 months later the patient presented with pain of the shoulder due to hardware irritation. One distal and one proximal screw were removed and the fracture was reported to be consolidated. " this pi refers to "deficit due to a prominent proximal screw. The screw was removed 86 days after surgery".
 
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Brand NamePROXIMAL SCREW
Type of DeviceIMPLANT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer Contact
rose haas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8230184
MDR Text Key132486118
Report Number0009610622-2019-00030
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 01/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2019
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/17/2018
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: 01/09/2019 Patient Sequence Number: 1
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