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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS SALTO TALARIS IMPLANT - UNSPECIFIED ANKLE REPLACEMENT

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ASCENSION ORTHOPEDICS SALTO TALARIS IMPLANT - UNSPECIFIED ANKLE REPLACEMENT Back to Search Results
Catalog Number XXX-SALTO TALARIS IMPLANT
Device Problem Material Integrity Problem (2978)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative
An investigation has been initiated based on the reported information. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A facility reported that a physician had to revise a salto talaris total ankle because of some subsidence of the tibial component. Upon removing the implants, a black gooey substance was present within the space that was around the implant. No additional information has been provided after several attempts.
 
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Brand NameSALTO TALARIS IMPLANT - UNSPECIFIED
Type of DeviceANKLE REPLACEMENT
Manufacturer (Section D)
ASCENSION ORTHOPEDICS
8700 cameron road #100
8700 cameron road #100
austin TX
Manufacturer (Section G)
ASCENSION ORTHOPEDICS
8700 cameron road #100
austin TX
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 
6099362319
MDR Report Key11611824
MDR Text Key251674998
Report Number1651501-2021-00006
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
PMA/PMN Number
K060544
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberXXX-SALTO TALARIS IMPLANT
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 Received04/16/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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