• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS CADENCE INSERT, SIZE 2, LEFT, 7MM, NEUTRAL CADENCE TOTAL ANKLE SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ASCENSION ORTHOPEDICS CADENCE INSERT, SIZE 2, LEFT, 7MM, NEUTRAL CADENCE TOTAL ANKLE SYSTEM Back to Search Results
Catalog Number 10209217
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Implant Pain (4561)
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
3 of 3 reports. Same patient, same procedure, different products other mfg report numbers: 1651501-2021-00024 and 1651501-2021-00025. Report from a clinical study: patient sustained persistent ankle pain from (b)(6) 2019, with instability and muscle weakness. On (b)(6) 2019, a spect ct showed hot spots on both tibia and talus implant. Medial malleolus ot healed with hot spot. May be lack of integration of the implants. Reported as continuous pain, moderate severity, probably related to the device, possibly related to the procedure and unanticipated. Subject was treated with meds; no tendinopathy was found on the ultrasound. No issue was found with the tar so the medial malleolar plate removal was scheduled on (b)(6) 2021. Ae was reported as continuous, mild severity, not related to the device but possibly related to the procedure, and unanticipated.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCADENCE INSERT, SIZE 2, LEFT, 7MM, NEUTRAL
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 Key11971605
MDR Text Key256015831
Report Number1651501-2021-00026
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,Followup
Report Date 09/30/2021
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 Date11/30/2020
Device Catalogue Number10209217
Device Lot NumberPN6794-2G
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 Received09/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/29/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-