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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN STANDARD GAMMA NAIL (SGN) CASE 6 IMPLANT

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STRYKER TRAUMA KIEL UNKNOWN STANDARD GAMMA NAIL (SGN) CASE 6 IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem No Code Available (3191)
Event Date 12/14/2015
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 is unknown.
 
Event Description
This product inquiry addresses 5 postoperative intra-articular lag screw protrusions in conjunction to the sgn system (1 event), tgn system (1 event) and gamma3 system (3 events). No treatment as patient was asymptomatic. It was not possible to ascertain specific device or patient information from the article, a review of the complaint handling database revealed that the events had not been reported by the hospital or by the author of the publication, therefore 11 complaints were initiated retrospectively. The manufacturer became aware by an italian publication "how evolution of the nailing system improves results and reduces orthopedic complications: more than 2000 cases of trochanteric fractures treated with the gamma nail system¿, published on 14th december 2015 regarding the gamma system (sgn, tgn, gamma3 ¿ all trochanteric nails) that in sum 63 patients had been observed presenting 11 adverse events in a period from january 1997 to december 2011.
 
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Brand NameUNKNOWN STANDARD GAMMA NAIL (SGN) CASE 6
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
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6123307
MDR Text Key60749146
Report Number0009610622-2016-00544
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 10/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_KIE
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 Received10/27/2016
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: 11/22/2016 Patient Sequence Number: 1
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