MAUDE Adverse Event Report: BIOHORIZONS INC. BIOHORIZONS INC.; DENTAL IMPLANT

Model Number PGCMA

Device Problem No Apparent Adverse Event (3189)

Patient Problem Insufficient Information (4580)

Event Date 01/08/2024

Event Type  Injury  

Manufacturer Narrative

Cause of the issue: during the migration of biohorizon¿s account from development to production, the fda gateway was mapped to emdr form version 2015 instead of 2021.The incorrect mapping to form version 2015 resulted in the submissions failing to move through the fda gateway.Impact: the records impacted were stuck in "submission in progress" state causing them to not advance to the fda.Impacted records count: (b)(4) emdr records out of a total (b)(4) emdr's in the system.Corrective actions.Biohorizons: biohorizons is issuing a supplier corrective action request (scar) to our vendor sparta.This will allow biohorizons to formally document the issue, actions taken by sparta to correct, and along with sparta actions taken to prevent the reoccurrence of this event.Scar number (b)(4) was issues to sparta to document the event.Sparta: to resolve the issue, sparta corrected the emdr form version mapping to 2021 for the biohorizons production account.The fix does not retrospectively re-submit the impacted records to the fda.To accomplish this additional step are needed to re-submit the impacted records to the fda.These steps are: 1.Update the mdr submission status on each record to a blank value.2.Update h10 field with mfg narrative for the late submission.3.Using trackwise digital platform automation, progress the impacted records to "failed fda." 4.Using trackwise digital platform automation, progress the impacted records to "submission in progress fda." preventative actions: this sequence of events which led to the issue will not occur again for biohorizons because the emdr form version mapping is a one-time activity.During the time of production deployment, biohorizons was a new customer of sparta.Sparta has raised the event to the product organization in exploring the options to remove any retired fda form references from the system.One of the options is for new customers to remove the old form version and verify the current fda version is appearing within the new customers production environment.Moreover, to facilitate early identification of fda submission issues, a report will be built to identify emdr records in "submission in progress" state for a defined period of time.

Event Description

Hex fractured.Vulcan complaint # (b)(4).Vulcan has sent replacement.

• Brand Name: BIOHORIZONS INC.
• Type of Device: 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: 18774212
• MDR Text Key: 336184547
• Report Number: 1060818-2024-00190
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K223697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PGCMA
• Device Catalogue Number: PGCMA
• Device Lot Number: 2100108
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention