MAUDE Adverse Event Report: ACE SURGICAL SUPPLY INFINTY; OCTAGON IMPLANT

Model Number	504810
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Loss of implant integration.

• Brand Name: INFINTY
• Common Device Name: OCTAGON IMPLANT
• Manufacturer (Section D): ACE SURGICAL SUPPLY; 1034 pearl st; brockton MA 02301
• Manufacturer (Section G): ACE SURGICAL SUPPLY; 1034 pearl st; brockton MA 02301
• Manufacturer Contact: bryanna derocha ; 1034 pearl st; brockton, MA 02301 ; 8004413100
• MDR Report Key: 17353181
• Report Number: 1287163-2023-54104
• Device Sequence Number: 20344063
• Product Code: DZE
• UDI-Device Identifier: E0HM5048101
• UDI-Public: E0HM5048101
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K103790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 07/10/2023

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 Model Number: 504810
• Device Catalogue Number: 504810
• Device Lot Number: C00176
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Unknown