MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS CADENCE IMPLANT-UNSPECIFIED; CADENCE TOTAL ANKLE SYSTEM|

Catalog Number XXX-CADENCE IMPLANT

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

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

It was reported that during implantation of cadence prosthesis, the 2 malleolus were broken, so the surgeon had to perform osteosynthesis.The surgeon indicated the event could be linked to procedure.The event lead to surgical delay, unknown for how long.

Manufacturer Narrative

As the lot number was not submitted, a review of the lot records could not be conducted to discover if there were any indications of problems that could have caused or contributed to the complaint.No components were returned to integra for investigation.As such, the failure could not be confirmed and a possible root cause could not be found.

• Brand Name: CADENCE IMPLANT-UNSPECIFIED
• 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: sonia irizarry ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 8162390
• MDR Text Key: 130321871
• Report Number: 1651501-2018-00062
• 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: foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-CADENCE IMPLANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2018
• 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