• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITH & NEPHEW, INC. UNKN EVOS PLATING PLATES PLATE, FIXATION, BONE Back to Search Results
Catalog Number 72465209
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key12297818
MDR Text Key265778120
Report Number1020279-2021-06254
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/06/2021
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 Number72465209
Device LOT Number19MM06891
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 Received08/27/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/10/2019
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
-
-