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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. SALTO TALARIS TALAR COMPONENT

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TORNIER S.A.S. SALTO TALARIS TALAR COMPONENT Back to Search Results
Model Number SIZE 1 LEFT
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

Patient had infection after total ankle arthroplasty performed (b)(6) 2015. Dr. (b)(6) removed salto talaris tibial insert as a precaution and performed i&d & replaced old tibial insert with new tibial insert (b)(6) 2015 (see mfr report 3000931034-2015-00127). Dr. (b)(6) then went back to surgery with patient (b)(6) 2015 & removed all salto talaris components due to continuous infection. Antibiotic spacer was implanted into patient.

 
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. Not returned to manufacturer.

 
Event Description

Patient had infection after total ankle arthroplasty performed (b)(6) 2015. Dr. (b)(6) removed salto talaris tibial insert as a precaution and performed i&d & replaced old tibial insert with new tibial insert (b)(6) 2015 (see mfr report 3000931034-2015-00127). Dr. (b)(6) then went back to surgery with patient (b)(6) 2015 & removed all salto talaris components due to continuous infection. Antibiotic spacer was implanted into patient.

 
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Brand NameSALTO TALARIS TALAR COMPONENT
Type of DeviceSALTO TALARIS TALAR COMPONENT
Manufacturer (Section D)
TORNIER S.A.S.
161 rue lavoisier
montbonnot saint martin, 38330
FR 38330
Manufacturer (Section G)
TORNIER SAS
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 Key5088341
MDR Text Key26188654
Report Number3000931034-2015-00141
Device Sequence Number1
Product Code HSN
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK130533
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/31/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/18/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2019
Device MODEL NumberSIZE 1 LEFT
Device Catalogue NumberLJU211
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 Received08/31/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/22/2014
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: 09/18/2015 Patient Sequence Number: 1
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