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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. SALTO TALARIS TIBIAL INSERT LEFT SIZE 1

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TORNIER S.A.S. SALTO TALARIS TIBIAL INSERT LEFT SIZE 1 Back to Search Results
Model Number THICKNESS 8 MM
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 07/02/2015
Event Type  Injury  
Event Description

Patient has infection after total ankle arthroplasty performed on (b)(6) 2015. Surgeon performed i and d and removed salto talaris tibial insert as a precaution.

 
Manufacturer Narrative

This is the initial report submitted regarding this surgical event and medical device.

 
Manufacturer Narrative

Medical device is manufactured in accordance with our specifications. Root cause of reported event could not be confirmed. Known inherent risk of procedure, the link with the concerned device is highly improbable this is the final report submitted regarding this surgical event and medical device. The not returned to manufacturer.

 
Event Description

Patient has infection after total ankle arthroplasty performed on (b)(6) 2015. Surgeon performed i&d and removed salto talaris tibial insert as a precaution.

 
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Brand NameSALTO TALARIS TIBIAL INSERT LEFT SIZE 1
Type of DeviceSALTO TALARIS TIBIAL INSERT LEFT SIZE 1
Manufacturer (Section D)
TORNIER S.A.S.
161 rue lavoisier
montbonnot saint martin, 38330
FR 38330
Manufacturer Contact
segolene pollet
161 rue lavoisier
montbonnot saint martin, 38330
FR   38330
76613500
MDR Report Key4945043
MDR Text Key6635308
Report Number3000931034-2015-00127
Device Sequence Number1
Product Code HSN
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK060544
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/02/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/24/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2018
Device MODEL NumberTHICKNESS 8 MM
Device Catalogue NumberLJU245
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/05/2013
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: 07/24/2015 Patient Sequence Number: 1
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