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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS VOLAR PLATE 4H L STD 56MM PLATE, FIXATION, BONE

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SMITH & NEPHEW, INC. EVOS VOLAR PLATE 4H L STD 56MM PLATE, FIXATION, BONE Back to Search Results
Model Number 72468104
Device Problem Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/22/2020
Event Type  Injury  
Event Description

It was reported that during a procedure no locking screw was inserted in one of the distal locking holes. Once reduction was retained, the cortex screw was removed and a locking screw was inserted. The locking tabs, however, were too damaged and no screw could be placed in that hole. A delay of less than or equal to 30 minutes was reported. The procedure was completed with the same device.

 
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Brand NameEVOS VOLAR PLATE 4H L STD 56MM
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
1450 brooks road
memphis, TN 
MDR Report Key10698100
MDR Text Key211917074
Report Number1020279-2020-05512
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK181533
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/23/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/19/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number72468104
Device Catalogue Number72468104
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2021
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: 10/19/2020 Patient Sequence Number: 1
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