• 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 1, RIGHT, 6MM, 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 1, RIGHT, 6MM, NEUTRAL CADENCE TOTAL ANKLE SYSTEM Back to Search Results
Catalog Number 10209106
Device Problem Insufficient Information (3190)
Patient Problem Implant Pain (4561)
Event Date 05/29/2020
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 parts. Other mfg report numbers: 1651501-2021-00018 and 1651501-2021-00019. Report from a clinical study: revision surgery performed of polyethylene insert due to pain without evident reason. Subject sustained chronic ankle pain after the surgery. The event was reported to be continuous and of moderate severity. The investigator reported no relation to the study device however a possible relationship to the procedure (primary ankle arthroplasty).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCADENCE INSERT, SIZE 1, RIGHT, 6MM, 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 Key11971578
MDR Text Key256021729
Report Number1651501-2021-00020
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 07/29/2021
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 Catalogue Number10209106
Device Lot Number174093-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 Received07/12/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/08/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-