MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS CADENCE INSERT, SIZE 2, LEFT, 6MM, NEUTRAL; CADENCE TOTAL ANKLE SYSTEM

Catalog Number 10209216

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of the device history record was conducted and did not discover any indication of problems that could have caused or contributed to the complaint.The device was not returned for evaluation, therefore, the failure analysis to identify root cause to the end users experience could not be determined.

Event Description

2 of 2 reports.Other mfg report number: 1651501-2020-00011.A physician reported the cadence poly would not lock into tibial tray during a total ankle arthroplasty.Had to burn a poly and tibial implant to resolve.After trying for about 35 minutes it finally seated.Patient outcome and current status was good.

• Brand Name: CADENCE INSERT, SIZE 2, LEFT, 6MM, NEUTRAL
• Type of Device: CADENCE TOTAL ANKLE SYSTEM
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX 78754
• Manufacturer (Section G): ASCENSION ORTHOPEDICS; 8700 cameron road #100; austin TX 78754
• Manufacturer Contact: vivian nelson ; 1000 campus drive; princeton, NJ 08536 ; 6099362319
• MDR Report Key: 10358141
• MDR Text Key: 202382775
• Report Number: 1651501-2020-00012
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K151459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10209216
• Device Lot Number: 183995G
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 66 YR