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

Catalog Number XXX-CADENCE IMPLANT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

The lot number is unknown, therefore a review of the lot record could not be conducted to determine if there were any indication of problems in fabrication that could have caused or contributed to the complaint.Product not returned to integra, failure analysis could not be conducted, and no definitive root cause could be determined.

Event Description

It was reported that during a clinical study, the patient had a fracture of both malleoli during implantation.The patient's bones were osteoporotic.An osteosynthesis of peroneal and tibial malleoli was performed.The event lead to surgical delay, not communicated for how long.

• 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: 7411337
• MDR Text Key: 104835159
• Report Number: 1651501-2018-00023
• 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: Other
• Type of Report: Initial
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-CADENCE IMPLANT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other