MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS CADENCE TALAR DOME, SIZE 2, LEFT; CADENCE TOTAL ANKLE SYSTEM

Catalog Number 10208202

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

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.Other mfg report numbers: 1651501-2021-00011, 1651501-2021-00013.A customer reported ankle impingement/tibial exostosis; event was treated with open reduction and internal fixation (orif) of stress fracture with 2 screws placed in medial malleolus.Arthroscopic debridement of synovium and excision of bone spurs in medial gutter.The patient was seen in clinic on (b)(6) 2021 status post ankle arthroscopy which occurred on (b)(6) 2021.The patient had ongoing ankle pain since (b)(6) of 2018.

Manufacturer Narrative

The cadence talar dome was not returned for evaluation, therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.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.

• Brand Name: CADENCE TALAR DOME, SIZE 2, LEFT
• Type of Device: CADENCE TOTAL ANKLE SYSTEM
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX
• MDR Report Key: 11749699
• MDR Text Key: 248797538
• Report Number: 1651501-2021-00012
• Device Sequence Number: 1
• Product Code: HSN
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 10208202
• Device Lot Number: 172708
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1