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

Model Number 0550

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The health care provider reported via manufacturer representative that after the physician cut the rod of the prosthesis during the procedure and when they were about the put the prosthesis in the ear, the prosthesis was broken.There was no damaged and no broken pieces remain inside the patients body.There was no delay with the procedure.The procedure was completed with backup product.There was no patient impact.

• Brand Name: PROSTHESIS - FLEX HA
• Type of Device: REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: christy cain ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328353
• MDR Report Key: 8893069
• MDR Text Key: 155653631
• Report Number: 1045254-2019-00383
• Device Sequence Number: 1
• Product Code: ETA
• UDI-Device Identifier: 00681490024426
• UDI-Public: 00681490024426
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K904239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0550
• Device Catalogue Number: 0550
• Device Lot Number: 0213544652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2019
• Date Device Manufactured: 06/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1