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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA3 NAIL 200 X 11 MM IMPLANT

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STRYKER TRAUMA KIEL UNKNOWN GAMMA3 NAIL 200 X 11 MM IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Date 05/07/2019
Event Type  Injury  
Manufacturer Narrative
This complaint has been reported during a literature review performed by the post market surveillance group. 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 study from (b)(6). The title of this report is ¿migration of the lag screw after intramedullary treatment of ao/ota 31. A2. 1-3 pertrochanteric fractures does not result in higher incidence of cut-outs, regardless of which implant was used: a comparison of gamma nail with and without u-blade (rc) lag screw and proximal femur nail antirotation (pfna)¿ which was published on 7-may 2019 and is associated with the stryker gamma nailing system. Within that publication, post-operative complications/ adverse events were reported. It was not possible to ascertain specific device catalog or patient details from the article, 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 journal. This product inquiry addresses central cut-out occurred three weeks later leading to a total hip arthroplasty. 1 out of 6 cases. The study states, ¿a central cut-out occurred three weeks later and the patient had to undergo a total hip arthroplasty. Despite adequate fracture reduction, poor bone quality and suboptimal placement of the blade in the femoral head-neck fragment led to the cut-out. ¿.
 
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Brand NameUNKNOWN GAMMA3 NAIL 200 X 11 MM
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 Key9125480
MDR Text Key165963925
Report Number0009610622-2019-00740
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 09/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2019
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 Received09/03/2019
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: 09/26/2019 Patient Sequence Number: 1
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