MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS CADENCE INSERT, SIZE 2, RIGHT, 8MM, NEUTRAL; CADENCE TOTAL ANKLE SYSTEM

Model Number 10209208

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Osteolysis (2377)

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.Other mfg report numbers: 1651501-2021-00015, and 1651501-2021-00016.Clinical study - cadence total ankle system clinical study had an adverse event report of ¿sclerosis of distal tibia¿ with the description of ¿per principal investigator: increased sclerosis of the distal tibia implant interference with some osteolysis noted on imagining.¿ ¿probably related¿ to the study device.No additional information is available.

Event Description

N/a.

Manufacturer Narrative

Updated fields: d9, g3, g6, h2, h3, h4, h6, h10.The cadence insert 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 INSERT, SIZE 2, RIGHT, 8MM, NEUTRAL
• 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: 11942994
• MDR Text Key: 263604178
• Report Number: 1651501-2021-00017
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 10381780238591
• UDI-Public: 10381780238591
• 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: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2022
• Device Model Number: 10209208
• Device Catalogue Number: 10209208
• Device Lot Number: PN7060-G
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1