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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS CADENCE TALAR DOME, SIZE 3, RIGHT CADENCE TOTAL ANKLE SYSTEM

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ASCENSION ORTHOPEDICS CADENCE TALAR DOME, SIZE 3, RIGHT CADENCE TOTAL ANKLE SYSTEM Back to Search Results
Catalog Number 10208103
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Implant Pain (4561)
Event Date 03/10/2021
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
2 of 3 reports. Same patient, same procedure, different products. Other mfg report numbers: 1651501-2021-00021, and 1651501-2021-00023. Report from a clinical study: ankle stiffness; per data review conducted on 26 january 2021, ¿ankle stiffness¿ was reported on (b)(6) 2021, in the (b)(6) clinical study. The description stated ¿painless ankle stiffness for 6 weeks limited dorsiflexion inducing asymmetrical stairs descent¿. This event was determined to be not serious, mild in severity grade, possibly related to device and possibly related to the procedure. No treatment was required and this event remains ongoing. Additional information received on june 4, 2021: subject sustained antero-medial ankle pain and documented impingement on pet scan from (b)(6) 2021. Ae frequency is reported as intermittent and of moderate severity. The event was classified not-serious and unanticipated by the study investigator. The event was reported as not related to the device but possibly related to the procedure. Subject underwent antero-medial release on (b)(6) 2021. Operated ankle: right. Primary diagnosis: primary arthritis. Previous surgeries: none. Implant date: (b)(6) 2019.
 
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Brand NameCADENCE TALAR DOME, SIZE 3, RIGHT
Type of DeviceCADENCE TOTAL ANKLE SYSTEM
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 Key11971590
MDR Text Key265678668
Report Number1651501-2021-00022
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
PMA/PMN Number
K151459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,study
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/01/2020
Device Catalogue Number10208103
Device Lot NumberQJ0459-G
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/21/2016
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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