MAUDE Adverse Event Report: ACE SURGICAL SUPPLE INFINITY; INFINTY OCTAGON BONE LEVEL

Model Number	504110BL
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The implant was rotating so primary stability was not achieved.

• Brand Name: INFINITY
• Common Device Name: INFINTY OCTAGON BONE LEVEL
• Manufacturer (Section D): ACE SURGICAL SUPPLE; 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: 17353193
• Report Number: 1287163-2023-54097
• Device Sequence Number: 14963049
• Product Code: DZE
• UDI-Device Identifier: E0HM504110BL1
• UDI-Public: E0HM504110BL1
• 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): 07/17/2023

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: 504110BL
• Device Catalogue Number: 504110BL
• Device Lot Number: B91595
• 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: Other
• Patient Age: 44 YR
• Patient Sex: Unknown