MAUDE Adverse Event Report: BIOHORIZONS BIOHORIZONS; DENTAL IMPLANT

Model Number	P1410.3807
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed to osseointegrate.
Additional Manufacturer Narrative
Issue: emdr records submitted to the fda within the sparta emdr portal were not received by the fda and remained in a state of submission in progress.Cause of the issue: fda maintenance/patch window caused the records to remain stuck and would not go through.Impact: the records impacted were stuck in "submission in progress" state causing them to not advance to the fda.Corrective actions: biohorizons: biohorizons created a support case with vendor sparta reporting the records stuck in the state of submission in progress.Biohorizons requested sparta to provide the cause to why records were not progressed to the fda.Additionally, field h10 is being updated with the events as they have unfolded.Sparta: contacted the fda to determine the root cause of the issue and what steps were required.Fda advised sparta support to resubmit the records.Sparta advised biohorizons that the issue was industry wide.The records were submitted during an unscheduled emergency fda maintenance patch window which caused the records to not go through.Preventative actions: the sequence of the events was outside the control of sparta and biohorizons.However, as part of client review, sparta is pro-actively monitoring the biohorizons org for records not advancing.During this monitoring, sparta is staying in constant contact with the fda regarding any records for the biohorizons org that does not receive the acknowledgements back from the fda gateway.This action is being addressed daily by sparta.Biohorizons is monitoring the records daily as well and continuing to file support cases with sparta for any records that are remaining in a status of submission in progress.

• Brand Name: BIOHORIZONS
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOHORIZONS; 2300 riverchase ctr; birmingham AL 35244
• MDR Report Key: 18961282
• Report Number: 1060818-2024-60086
• Device Sequence Number: 8030760
• Product Code: DZE
• UDI-Device Identifier: E219P141038071
• UDI-Public: E219P141038071
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 03/13/2024

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: P1410.3807
• Device Catalogue Number: P1410.3807
• Device Lot Number: 0010123384
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 03/22/2024
• 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