MAUDE Adverse Event Report: GRACE MEDICAL, INC. ECLIPSE PISTON; PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT

Catalog Number 472-450

Device Problem Malposition of Device (2616)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

The loop was found to be opened and twisted upon receipt.This indicated that the loop was opened, as if removed from the incus.Heat was applied to the opened loop and it closed meeting specifications.Following the closure, the loop did not re-open.

Event Description

It was reported that this device was explanted during a revision surgery, as the loop of the stapes prosthesis was found to be in the opened position and lying in the middle ear space.

• Brand Name: ECLIPSE PISTON
• Type of Device: PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT
• Manufacturer (Section D): GRACE MEDICAL, INC.; 8500 wolf lake drive; suite 110; memphis TN 38133 4104
• Manufacturer (Section G): GRACE MEDICAL, INC.; 8500 wolf lake drive; suite 110; memphis TN 38133 4104
• Manufacturer Contact: carlyn reynolds ; 8500 wolf lake drive; suite 110; memphis, TN 38133-4104 ; 9013860990
• MDR Report Key: 8383243
• MDR Text Key: 137593596
• Report Number: 1000022662-2019-00001
• Device Sequence Number: 1
• Product Code: ETB
• UDI-Device Identifier: 00844505009362
• UDI-Public: 00844505009362
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/28/2022
• Device Catalogue Number: 472-450
• Device Lot Number: 56704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2017
• 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
• Patient Outcome(s): Required Intervention