MAUDE Adverse Event Report: Innomed, Inc. Patella Cover Plate Medium; Orthopedic Manual Surgical Instrument

Model Number	4230-02
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/30/2026
Type of Reportable Event	Other

• Brand Name: Patella Cover Plate Medium
• Common Device Name: Orthopedic Manual Surgical Instrument
• Manufacturer (Section D): Innomed, Inc.; 103 estus drive; savannah GA 31404 -144
• Manufacturer Contact: aaron ingram ; 103 estus drive; savannah, GA 31404--144 ; +1(912)236-0000
• MDR Report Key: 50721453
• Report Number: 1833053-2026-00002
• Device Sequence Number: 13317423
• Product Code: LXH
• UDI-Device Identifier: 00840277107824
• UDI-Public: 00840277107824
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 4230-02
• Device Catalogue Number: 4230-052
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 216 LB
• Patient Race: Asian