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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
Catalog Number 72454406N
Device Problem Break (1069)
Patient Problem Failure of Implant (1924)
Event Date 07/23/2021
Event Type  Injury  
Event Description

It was reported that, during physical therapy, lateral evos 3. 5/2. 7 distal fibula plate and anterolateral partial articular evos 2. 7/3. 5 distal tibia plate, broke, therefore a revision surgery was performed on (b)(6) 2021 for plate removal. The current health status of the patient is unknown.

 
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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
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key12297713
MDR Text Key265765430
Report Number1020279-2021-06253
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK170457
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/09/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/09/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number72454406N
Device LOT Number19GM01189
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2019
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: 08/09/2021 Patient Sequence Number: 1
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