MAUDE Adverse Event Report: MEDTRONIC XOMED INC. PROSTHESIS - STAPES; REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

Model Number 1156603

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/03/2016

Event Type  Injury  

Manufacturer Narrative

Information received from a sus voluntary event report; mw5061747.No additional information can be obtained.Concomitant device: ¿big easy piston¿, product number unknown, lot unknown.Product evaluation: analysis results not available; no devices were returned for evaluation.

Event Description

It was reported that the "patient had a previous staple prosthesis replaced.It had failed/broken during or after previous procedure" and required a procedure and replacement to repair.There was no reported patient impact.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROSTHESIS - STAPES
• Type of Device: REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• Manufacturer Contact: michelle alford ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328197
• MDR Report Key: 5697481
• MDR Text Key: 46496371
• Report Number: 1045254-2016-00172
• Device Sequence Number: 1
• Product Code: ETA
• Combination Product (y/n): N
• PMA/PMN Number: K002897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2021
• Device Model Number: 1156603
• Device Catalogue Number: 1156603
• Device Lot Number: 0207247969
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/26/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention