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

Model Number	468-450
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	05/27/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT
• Manufacturer (Section D): GRACE MEDICAL, INC.; 8500 wolf lake drive; suite 110; memphis,
• MDR Report Key: 10227374
• Report Number: 1000022662-2020-00001
• Device Sequence Number: 3233885
• Product Code: ETB
• UDI-Device Identifier: 00844505002011
• UDI-Public: 00844505002011
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 07/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Weight: 65