MAUDE Adverse Event Report: BioHorizons Inc. BioHorizons Inc.; Dental Implant

Model Number	PYHYB
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Abutment screw loose.
Additional Manufacturer Narrative
This report is being submitted as part of a remediation / retrospective review per capa-0029 involving a review of complaints from 12/20/2024 to 09/28/2026.

• Brand Name: BioHorizons Inc.
• Common Device Name: Dental Implant
• Manufacturer (Section D): BioHorizons Inc.; 2300 riverchase center; birmingham AL 35244
• Manufacturer (Section G): BioHorizons Inc.; 2300 riverchase center; birmingham AL 35244
• Manufacturer Contact: anissa smith ; 2300 riverchase center; birmingham, AL 35244
• MDR Report Key: 50913560
• Report Number: 1060818-2026-19540
• Device Sequence Number: 5803704
• Product Code: DZE
• UDI-Device Identifier: 00847236012120
• UDI-Public: 00847236012120
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K223697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 09/28/2026

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: PYHYB
• Device Catalogue Number: PYHYB
• Device Lot Number: 2402318
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 09/28/2026
• 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