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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PLATE PLATE, FIXATION, BONE

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PLATE PLATE, FIXATION, BONE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Failure of Implant (1924); Impaired Healing (2378); Swelling/ Edema (4577)
Event Date 09/11/2020
Event Type  malfunction  
Event Description
On (b)(6) 2020 left tibia/fibula fracture repair; required orif with plate, screws, and washer; pt continues to suffer with pain, swelling, superficial wounds as of this date. Concern for implant(s) rejection reaction. Pt having implants removed due to ongoing issues. Fda safety report id# (b)(4).
 
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Brand NamePLATE
Type of DevicePLATE, FIXATION, BONE
MDR Report Key11619047
MDR Text Key244299100
Report NumberMW5100574
Device Sequence Number1
Product Code HRS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/02/2021
6 Devices were Involved in the Event: 1   2   3   4   5   6  
1 Patient was Involved in the Event
Date FDA Received04/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/05/2021 Patient Sequence Number: 1
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