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

Model Number 468-450

Device Problem Material Twisted/Bent (2981)

Patient Problem Inadequate Pain Relief (2388)

Event Date 05/27/2020

Event Type  Injury  

Manufacturer Narrative

The investigation found no instrument marks or damage anywhere on the implant other than the implant being bent.The implant was activated with heat, and the implant hook closed properly and the bent shaft straightened as designed.The implant performed as intended.

Event Description

It was reported that the surgeon placed the prosthesis successfully several months ago.At least weeks/months later at follow up appointment, patient had mentioned to the surgeon that their hearing had not improved.After months of no improvement the physician decided to go in and investigate.When the physician opened up the patient, he found the shaft bent.The surgeon decided to place another prosthesis to restore the patient's hearing.

• Brand Name: ECLIPSE PISTON
• Type of Device: PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT
• Manufacturer (Section D): GRACE MEDICAL, INC.; 8500 wolf lake drive; suite 110; memphis,
• Manufacturer (Section G): GRACE MEDICAL, INC.; 8500 wolf lake drive; suite 110; memphis, tn
• Manufacturer Contact: carlyn reynolds ; 8500 wolf lake drive; suite 110; memphis, tn ; 3860990
• MDR Report Key: 10227374
• MDR Text Key: 197403434
• Report Number: 1000022662-2020-00001
• Device Sequence Number: 1
• Product Code: ETB
• UDI-Device Identifier: 00844505002011
• UDI-Public: 00844505002011
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K063374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2024
• Device Model Number: 468-450
• Device Catalogue Number: 468-450
• Device Lot Number: 65666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Date Manufacturer Received: 06/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2019
• 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
• Patient Age: 86 YR
• Patient Weight: 65