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

Model Number	10208102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
2 of 3 reports.Other mfg report numbers: 1651501-2021-00015, 1651501-2021-00017.Clinical study - (b)(6) 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.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.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.
Event or Problem Description
N/a.

• Brand Name: CADENCE TALAR DOME, SIZE 2, RIGHT
• Common Device Name: CADENCE TOTAL ANKLE SYSTEM
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX
• MDR Report Key: 11942991
• Report Number: 1651501-2021-00016
• Device Sequence Number: 19156648
• Product Code: HSN
• UDI-Device Identifier: 10381780239321
• UDI-Public: 10381780239321
• Combination Product (Y/N): N
• PMA/510(K) Number: K151459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 10208102
• Device Catalogue Number: 10208102
• Device Lot Number: QJ0786
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 06/20/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1