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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 2.4MM X 22MM LCK SCR T7 S-T PLATE, FIXATION, BONE

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SMITH & NEPHEW, INC. EVOS 2.4MM X 22MM LCK SCR T7 S-T PLATE, FIXATION, BONE Back to Search Results
Model Number 72412422
Device Problem Difficult to Insert (1316)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/16/2020
Event Type  malfunction  
Event Description
It was reported that during a trauma procedure, the head of the evos 2. 4mm x 22mm locking screw t7 s-t did sit high when engaged into the plate. The implanted screw had to be removed and a different screw was used to completed the procedure. It is unknown if there was any surgical delay. The patient was not injured beyond the described event.
 
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Brand NameEVOS 2.4MM X 22MM LCK SCR T7 S-T
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
sarah freestone
1450 brooks rd.
memphis, TN 38116
0447940038
MDR Report Key10394365
MDR Text Key202498952
Report Number1020279-2020-03855
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140814
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72412422
Device Catalogue Number72412422
Device Lot Number20DM02147
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/19/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/03/2020
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: 08/11/2020 Patient Sequence Number: 1
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