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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 35MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 35MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71645035
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Abrasion (1689); Bacterial Infection (1735)
Event Date 04/07/2021
Event Type  Injury  
Event Description
It was reported that, due to a fall on (b)(6) 2020, a patient experienced a right tibial fracture which required a temporary treatment with an external fixator on (b)(6) 2020. This external fixator was removed on (b)(6) 2020 and after a right tibial internal infixation surgery with trigen low profile screw 5. 0mm x 35mm performed the same day, the patient experienced secretion and wound healing problems with the presence of staphylococcus aureus. A revision surgery was performed on 07-apr-2021 to treat this adverse event. The trigen low profile screw 5. 0mm x 35mm (x2), int hex cap scr 5. 0mm x 35mm, trigen low profile screw 5. 0mm x 40mm and trigen low profile screw 5. 0mm x 55mm were explanted during this revision surgery. It is unknown if the explanted device was substituted with a smith and nephew implant. The patient outcome is unknow.
 
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Brand NameTRIGEN LOW PROFILE SCREW 5.0MM X 35MM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key11817058
MDR Text Key250360504
Report Number1020279-2021-04178
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K111025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number71645035
Device Catalogue Number71645035
Device Lot Number19FM14936
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/20/2019
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: 05/13/2021 Patient Sequence Number: 1
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