MAUDE Adverse Event Report: ACE SURGICAL INTERNAL HEX IMPLANT; DENTAL IMPLANT

Model Number	203711
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual evaluation of product under 65x magnification showed no signs of physical defects.
Event or Problem Description
Bone quality.

• Brand Name: INTERNAL HEX IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ACE SURGICAL; 1034 pearl st; brockton 02301
• Manufacturer (Section G): ACE SURGICAL; 1034 pearl st; brockton MA 02301
• Manufacturer Contact: franco desruisseaux ; 1034 pearl; brockton, MA 02301
• MDR Report Key: 13168609
• Report Number: 1287163-2021-02903
• Device Sequence Number: 5432937
• Product Code: DZE
• UDI-Device Identifier: 00614950004645
• UDI-Public: 00614950004645
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: K102981
• 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): 12/29/2021

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
• Device Model Number: 203711
• Device Catalogue Number: 203711
• 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: 12/02/2021
• Initial Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 51 YR
• Patient Sex: Male