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

Model Number	402-450
Health Effect - Clinical Codes	Hearing Impairment (1881); Inflammation (1932)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.The review of the device history records associated with the device did not find any nonconformances.There were no products in finished goods inventory with this part number and lot number combination to check.Additionally, there have been no other reported complaints for this part number and lot number.Limited information has been provided at this time.If additional information is received, a follow-up report will be submitted.
Event or Problem Description
It was initially reported that "there is patient loss hearing after operation of fluoroplastic piston.The patient hear for the first 3 days after operation then loss hearing." it was later reported "after the operation, the patient loss hearing for 3 days then returned hear that is because of the patient was suffering from inflammation then he treated from this inflammation.".

• Brand Name: FLUOROPLASTIC PISTON
• Common Device Name: PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT
• Manufacturer (Section D): GRACE MEDICAL, INC.; 8500 wolf lake drive; suite 110; memphis TN 38133 4104
• MDR Report Key: 12374241
• Report Number: 1000022662-2021-00001
• Device Sequence Number: 14586511
• Product Code: ETB
• UDI-Device Identifier: 00844505000567
• UDI-Public: 00844505000567
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K060518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/01/2021

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: 01/28/2025
• Device Model Number: 402-450
• Device Catalogue Number: 402-450
• Device Lot Number: 72151
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2021
• Initial Report FDA Received Date: 08/26/2021
• 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