MAUDE Adverse Event Report: ACE SURGICAL SUPPLY CO., INC. ACE SURGICAL SUPPLY CO., INC.; DENTAL IMPLANT

Model Number	305011
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed to osseointegrate.
Additional Manufacturer Narrative
These records are being submitted following the completion of the necessary system updates to correctly reflect the manufacturer information.Configuration and validation documentation updates were required to enable submission of the manufacturer, ace surgical supply, along with the contact office information for biohorizons.At the time of the initial report, it was not communicated that the devices would be returned for processing.Once the product was returned, it necessitated the configuration updates and validation changes described above.These updates will support proper handling of future submissions.The records included in this submission reflect the originally reported devices provided to biohorizons.

• Brand Name: ACE SURGICAL SUPPLY CO., INC.
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ACE SURGICAL SUPPLY CO., INC.; 2300 riverchase center; suite 801; birmingham AL 35244
• Manufacturer (Section G): ACE SURGICAL SUPPLY CO., INC.; 2300 riverchase center; birmingham AL 35244
• Manufacturer Contact: anissa smith ; 2300 riverchase center; birmingham, AL 35244
• MDR Report Key: 25209286
• Report Number: 1287163-2026-10005
• Device Sequence Number: 8873613
• Product Code: DZE
• UDI-Device Identifier: 00614950005284
• UDI-Public: 00614950005284
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K103790
• 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
• Report Source: Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/29/2026

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: 305011
• Device Catalogue Number: 305011
• Device Lot Number: 18050027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 05/18/2026
• 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 Sex: Unknown