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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
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