MAUDE Adverse Event Report: Grace Medical, Inc. PARTIAL 3MM CENTERED HEAD; PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT

Model Number	270
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Implant broke when attempting to insert.

• Brand Name: PARTIAL 3MM CENTERED HEAD
• Common Device Name: PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT
• Manufacturer (Section D): Grace Medical, Inc.; 8500 wolf lake dr. suite 110; memphis TN 38133
• MDR Report Key: 50237501
• Report Number: 50237501
• Device Sequence Number: 21426115
• Product Code: ETB
• UDI-Device Identifier: 00844505000413
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/06/2026
• Report Date (Section F): 08/06/2026

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
• Operator of Device: Health Professional
• Device Model Number: 270
• Device Lot Number: 119991
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 08/13/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 238 LB
• Date Report Sent to FDA: 08/06/2026