MAUDE Adverse Event Report: GRACE MEDICAL, INC. CENTERED ALTO CONCISE PARTIAL; PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT

Model Number	655-075
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Grace medical was made aware via medsun program uf/importer report#: (b)(4).The product was returned and was determined that no defects/damages were found associated with the implant.The event described does not meet the criteria of a malfunction per the definition in 21 cfr 801.The device is labeled not to be used if the packaging is damaged and the user did not use the device when they noticed the implant was out of its holder.The review of the device history records associated with this device and lot number did not find any nonconformance.
Event or Problem Description
Grace medical customer service was made aware of a product failure via e-mail.The complaint captured and regulatory was notified via a medsun report uf/importer report#: (b)(4) by the fda.The user facility reported that the implant was uncapped and loose when peel pack was opened to the sterile field.
Event or Problem Description
Grace medical customer service was made aware of a product failure via e-mail.The complaint captured and regulatory was notified via a medsun report uf/importer report # (b)(4) by the fda.The user facility reported that the implant was uncapped and loose when peel pack was opened to the sterile field.
Additional Manufacturer Narrative
Grace medical was made aware via medsun program uf/importer report #(b)(4).The product was returned and was determined that no defects/damages were found associated with the implant.The event described does not meet the criteria of a malfunction per the definition in 21 cfr 801.The device is labeled not to be used if the packaging is damaged and the user did not use the device when they noticed the implant was out of its holder.The review of the device history records associated with this device and lot number did not find any nonconformance.

• Brand Name: CENTERED ALTO CONCISE PARTIAL
• Common Device Name: PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT
• Manufacturer (Section D): GRACE MEDICAL, INC.; 8500 wolf lake drive; suite 110; memphis TN 38133
• Manufacturer (Section G): GRACE MEDICAL, INC.; 8500 wolf lake drive; suite 110; memphis TN 38133
• Manufacturer Contact: mark melton ; 8500 wolf lake drive; suite 110; memphis, TN 38133 ; 9014974193
• MDR Report Key: 21564939
• Report Number: 1057421-2025-00001
• Device Sequence Number: 17236604
• Product Code: ETB
• UDI-Device Identifier: 00844505013383
• UDI-Public: 00844505013383
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K061853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 655-075
• Device Catalogue Number: 655-075
• Device Lot Number: 106216
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Male