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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 2.7/3.5 SUP DIST CLAV PL 5H L 89MM PLATE, FIXATION, BONE

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SMITH & NEPHEW, INC. EVOS 2.7/3.5 SUP DIST CLAV PL 5H L 89MM PLATE, FIXATION, BONE Back to Search Results
Model Number 72467305
Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900)
Patient Problems Arthritis (1723); Failure of Implant (1924); Pain (1994); Joint Laxity (4526)
Event Date 09/22/2020
Event Type  Injury  
Event Description
It was reported that the patient was operated with the evos clavicle plate and screws, for an pseudo arthrosis, patient had pain after 14 days, and x-ray revealed that all 5 lateral screws (1 cortex and 4 locking), had loosened and lay outside the plate and just beneath the skin. Revision surgery was performed to correct the problem.
 
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Brand NameEVOS 2.7/3.5 SUP DIST CLAV PL 5H L 89MM
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
5123913905
MDR Report Key10737993
MDR Text Key213149115
Report Number1020279-2020-05768
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K173293
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number72467305
Device Catalogue Number72467305
Device Lot Number19CM09621
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/03/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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