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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES STRATEC SYNTHES STRATEC PLATE AND SCREW

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SYNTHES STRATEC SYNTHES STRATEC PLATE AND SCREW Back to Search Results
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/27/2017
Event Type  Injury  
Event Description
Hardware failure.
 
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Brand NameSYNTHES STRATEC
Type of DevicePLATE AND SCREW
Manufacturer (Section D)
SYNTHES STRATEC
st. louis MO 63141
MDR Report Key6289693
MDR Text Key66236581
Report NumberMW5067539
Device Sequence Number1
Product Code HRS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 01/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/27/2017 Patient Sequence Number: 1
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