MAUDE Adverse Event Report: ACE SURGICAL SUPPLY CO. INFINITY EXTERNAL HEX IMPLANT; DENTAL IMPLANT

Model Number	404010
Medical Device Problem Codes	Failure to Osseointegrate (1863); Osseointegration Problem (3003); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Failed to osteointergrate.

• Brand Name: INFINITY EXTERNAL HEX IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ACE SURGICAL SUPPLY CO.; 10354 pearl street; brockton MA 02301
• Manufacturer (Section G): ACE SURGICAL SUPPLY CO.; 1034 pearl street; brockton MA 02301
• Manufacturer Contact: james weatherby ; 1034 pearl street; brockton, MA 02301 ; 8004413100
• MDR Report Key: 16979588
• Report Number: 1287163-2023-54071
• Device Sequence Number: 2543255
• Product Code: DZE
• UDI-Device Identifier: 00614950005468
• UDI-Public: 00614950005468
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K954513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 05/22/2023

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: 404010
• Device Catalogue Number: 404010
• Device Lot Number: 19030017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (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: 54 YR
• Patient Sex: Male