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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 3.5MM LCK COMP PL 12H 183MM PLATE, FIXATION, BONE

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SMITH & NEPHEW, INC. 3.5MM LCK COMP PL 12H 183MM PLATE, FIXATION, BONE Back to Search Results
Catalog Number 71829712
Device Problem Bent (1059)
Patient Problem Fracture, Arm (2351)
Event Date 10/30/2014
Event Type  Injury  
Manufacturer Narrative
Please review attached for the investigation results.
 
Event Description
It was reported that the implant was bent to almost 90 degrees.
 
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Brand Name3.5MM LCK COMP PL 12H 183MM
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
markus poettker
1450 brooks road
memphis, TN 38116
MDR Report Key6911296
MDR Text Key107635828
Report Number1020279-2017-00823
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K033669
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71829712
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 Received09/07/2017
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/03/2017 Patient Sequence Number: 1
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