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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA NAIL IMPLANT

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STRYKER TRAUMA KIEL UNKNOWN GAMMA NAIL IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Unstable (1667)
Patient Problems Failure of Implant (1924); Necrosis (1971)
Event Date 10/01/2019
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 pmcf report from (b)(6) medical center, (b)(6). The title of this report is ¿incidence of avascular necrosis of the femoral head after intramedullary nailing of femoral shaft fractures¿ which is associated with the stryker intramedullary nailing system. Within that publication, post-operative complications/ adverse events were reported which occurred from january 2010 to june 2014. It was not possible to ascertain specific device 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 5 complaints were initiated retrospectively for different adverse events mentioned in the report. This product inquiry addresses avascular necrosis of the femoral head (avnfh). The study reports, the overall incidence of avnfh after antegrade im nailing of femoral shaft fractures was 0. 2% (1 of 542 patients): the patient was a (b)(6)-year-old boy. A (b)(6)-year-old boy with an isolated closed fracture of the right femoral shaft was treated by antegrade intramedullary nailing with trochanteric fossa insertion. The 14-month postoperative radiographs showed fracture-healing, and the patient was pain-free. Twenty-one months after the injury, radiographs of the right hip showed early collapse of the femoral head that was consistent with avascular necrosis.
 
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Brand NameUNKNOWN GAMMA NAIL
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
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9245673
MDR Text Key170519291
Report Number0009610622-2019-00896
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeKR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 10/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2019
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 Received10/01/2019
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: 10/28/2019 Patient Sequence Number: 1
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