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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN EVOS PLATING PLATES PLATE, FIXATION, BONE

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SMITH & NEPHEW, INC. UNKN EVOS PLATING PLATES PLATE, FIXATION, BONE Back to Search Results
Lot Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Injury (2348)
Event Type  Injury  
Event Description
It was reported that, three months after an initial trauma surgery in which a fibula plate had been implanted, the patient developed an infection. An early revision surgery was performed to remove the plate. The infection healed and the patient was increasingly mobilising with crutches.
 
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Brand NameUNKN EVOS PLATING PLATES
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
w. william cannon drive 7000
austin, TX 78735
5123913906
MDR Report Key10505667
MDR Text Key206085953
Report Number1020279-2020-04477
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2021
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: 09/08/2020 Patient Sequence Number: 1
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