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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.
 
Event Description
N/a.
 
Manufacturer Narrative
The salto talaris implant was not returned for evaluation and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
 
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Brand Name
SALTO TALARIS IMPLANT - UNSPECIFIED
Type of Device
ANKLE REPLACEMENT
Manufacturer (Section D)
ASCENSION ORTHOPEDICS
8700 cameron road #100
8700 cameron road #100
austin TX
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
Type of Report Initial,Followup
Report Date 05/05/2021
1 Device was Involved in the Event
1 Patient was 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 Health Professional
Device Catalogue NumberXXX-SALTO TALARIS IMPLANT
Was Device Available for Evaluation? No
Date Manufacturer Received04/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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