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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS CADENCE INSERT, SIZE 2, RIGHT, 6MM, NEUTRAL CADENCE TOTAL ANKLE SYSTEM

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ASCENSION ORTHOPEDICS CADENCE INSERT, SIZE 2, RIGHT, 6MM, NEUTRAL CADENCE TOTAL ANKLE SYSTEM Back to Search Results
Catalog Number 10209206
Device Problem Appropriate Term/Code Not Available
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 the cadence implant was infected. The patient had a blister on the big toe, obtained during hiking and it got infected. She went to her doctor on (b)(6) 2018 with a swollen ankle. Her ankle was performing very well and had no issues until now. The doctor suspected an infection and called the patient to the operating room for implant exchange (same size). The implant was sent to the lab for infection analysis. The implant was removed without issue and visual inspection seemed normal.

 
Manufacturer Narrative

The complaint device was not returned for evaluation. A review of the lot records was conducted, and there were no indications of problems that could have caused or contributed to the complaint. As the implant was not returned for evaluation, a failure analysis could not be conducted and definitive root cause could not be found. If it is later returned, this complaint will be reopened and an evaluation conducted. However, from the description of the event the most likely root cause is an infection in the toe that led to an ankle infection.

 
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Brand NameCADENCE INSERT, SIZE 2, RIGHT, 6MM, NEUTRAL
Type of DeviceCADENCE 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
vivian nelson
311 enterprise drive
plainsboro , NJ 08536
6099362393
MDR Report Key7965593
Report Number1651501-2018-00057
Device Sequence Number1
Product CodeHSN
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/02/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/15/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number10209206
Device LOT NumberPN6900-G
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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