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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA3 NAIL CASE 1; IMPLANT

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STRYKER TRAUMA KIEL UNKNOWN GAMMA3 NAIL CASE 1; IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Information (3190); Insufficient Information (4580)
Event Date 12/19/2019
Event Type  Death  
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 literature published by department of orthopedics, suzhou dushuhu public hospital in china.The title of this report is ¿which implant is better for beginners to learn to treat geriatric intertrochanteric femur fractures: a randomised controlled trial of surgeons, metalwork, and patients¿ which is associated with the stryker ¿gamma3 nailing¿ system.The article can be found at https://doi.Org/10.1016/j.Jot.2019.11.003.This report includes research done on 169 patients between the period january 2011 to february 2017.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 (2) cases of death during hospitalization.The report states during hospitalization, four patients died.Three of them had acute pulmonary embolism or heart failure, and one had multiple organ failure.
 
Event Description
The manufacturer became aware of a literature published by department of orthopedics, suzhou dushuhu public hospital in china.The title of this report is ¿which implant is better for beginners to learn to treat geriatric intertrochanteric femur fractures: a randomised controlled trial of surgeons, metalwork, and patients¿ which is associated with the stryker ¿gamma3 nailing¿ system.The article can be found at https://doi.Org/10.1016/j.Jot.2019.11.003.This report includes research done on 169 patients between the period january 2011 to february 2017.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 (2) cases of death during hospitalization.The report states during hospitalization, four patients died.Three of them had acute pulmonary embolism or heart failure, and one had multiple organ failure.
 
Manufacturer Narrative
Please note correction made to section h1.
 
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Brand Name
UNKNOWN GAMMA3 NAIL CASE 1
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM  D-24232
MDR Report Key11132097
MDR Text Key225565927
Report Number0009610622-2021-00132
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 literature
Type of Report Initial,Followup
Report Date 03/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue NumberUNK_KIE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/14/2020
Initial Date FDA Received01/07/2021
Supplement Dates Manufacturer Received03/09/2021
Supplement Dates FDA Received03/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
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