MAUDE Adverse Event Report: ACE SURGICAL INFINITY OCTAGON BONE LEVEL; DENTAL IMPLANT

Model Number	503308BL
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual evaluation of product under 65x magnification showed no signs of physical defects.Mount is still attatched.
Event or Problem Description
Implant was never tight enough, was a spinner.

• Brand Name: INFINITY OCTAGON BONE LEVEL
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ACE SURGICAL; 1034 pearl; brockton MA 02301
• Manufacturer (Section G): ACE SURGICAL; 1034 pearl st; brockton MA 02301
• Manufacturer Contact: franco desruisseaux ; 1034 pearl st; brockton 02301
• MDR Report Key: 13180145
• Report Number: 1287163-2022-01033
• Device Sequence Number: 5364752
• Product Code: DZE
• UDI-Device Identifier: E0HM503308BL1
• UDI-Public: E0HM503308BL1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/05/2022

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: 503308BL
• Device Catalogue Number: 503308BL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2022
• Initial Report FDA Received Date: 01/06/2022
• 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: 51 YR
• Patient Sex: Female