MAUDE Adverse Event Report: BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS HYBRID ABUTMENT HEX; HEX HYBRID ABUTMENT

Model Number	PGHYB
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned for evaluation.Therefore, no conclusion may be drawn to attribute to the reported fractured device.For any reported known and verified lot number, a review of the device history record took place.No nonconformance was noted.Therefore, the device was manufactured to specifications.
Event or Problem Description
This report is a summary of one (1) malfunction event.A review of the event(s) involved a device experiencing a broken hex.No adverse event patient information was reported.No information regarding patient demographics have been provided.
Additional Manufacturer Narrative
No product was returned for evaluation.Therefore, no conclusion may be drawn to attribute to the reported fractured device.For any reported known and verified lot number, a review of the device history record took place.No nonconformance was noted.Therefore, the device was manufactured to specifications.
Event or Problem Description
This report is a summary of one (1) malfunction event.A review of the event(s) involved a device experiencing a broken hex.No adverse event patient information was reported.No information regarding patient demographics have been provided.

• Brand Name: BIOHORIZONS HYBRID ABUTMENT HEX
• Common Device Name: HEX HYBRID ABUTMENT
• Manufacturer (Section D): BIOHORIZONS IMPLANT SYSTEMS; 2300 riverchase center; birmingham AL 35244
• Manufacturer (Section G): BIOHORIZONS IMPLANT SYSTEMS; 2300 riverchase center; birmingham AL 35244
• Manufacturer Contact: anissa smith ; 2300 riverchase center; birmingham, AL 35244
• MDR Report Key: 16275262
• Report Number: 1060818-2022-18769
• Device Sequence Number: 11982153
• Product Code: NHA
• UDI-Device Identifier: 00847236012106
• UDI-Public: 00847236012106
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PGHYB
• Device Catalogue Number: PGHYB
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown