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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2 NAIL IMPLANT

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STRYKER TRAUMA KIEL UNKNOWN T2 NAIL IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Myocardial Infarction (1969)
Event Date 04/12/2019
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device evaluated by mfr: device disposition is unknown.
 
Event Description
This pi represents the myocardial infarction patient suffered between both surgeries. The pharmacist from the hospital reported the following event : "the consequences for the patient are therefore a double anaesthesia (2 operations instead of 1), and an extended operating time for the 1st operation. During the 2nd operation, the same problem. But the managers were very reactive to find an operational instrument. The 2nd operation (definitive nailing) took place 15 days later, with an extended hospital stay, increased discomfort for the patient due to the external fixator, in this elderly and fragile patient. In addition, between the two operations, she suffered a myocardial infarction, with a stay in cardiological intensive care, whose imputability for the surgery is difficult to prove. (this is my opinion as an orthopaedic surgeon, the opinion of an expert doctor could differ.
 
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Brand NameUNKNOWN T2 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
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8680334
MDR Text Key147445843
Report Number0009610622-2019-00481
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 06/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2019
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 Received05/13/2019
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: 06/07/2019 Patient Sequence Number: 1
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