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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 30MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 30MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71645030
Device Problem Failure to Osseointegrate (1863)
Patient Problem Inadequate Osseointegration (2646)
Event Date 02/27/2020
Event Type  Injury  
Event Description
It was reported that after an operation where the trigen low profile screw 5. 0mm x 30mm was implanted, a ct scan was performed and the ct image showed an incomplete fracture around the lpss.
 
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Brand NameTRIGEN LOW PROFILE SCREW 5.0MM X 30MM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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
sarah freestone
1450 brooks road
memphis, TN 38116
MDR Report Key9912945
MDR Text Key186742075
Report Number1020279-2020-01113
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K111025
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 11/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number71645030
Device Catalogue Number71645030
Device Lot Number19GM20517
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 Received11/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/26/2019
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: 04/01/2020 Patient Sequence Number: 1
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