MAUDE Adverse Event Report: INTRA-LOCK INTRA-LOCK; DENTAL IMPLANT

Model Number	MDL2513
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/10/2024
Type of Reportable Event	Serious Injury
Additional 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.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 scar24001 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 or Problem Description
Implant failed to osseointegrate.

• Brand Name: INTRA-LOCK
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): INTRA-LOCK; 2300 riverchase center; birmingham AL 35244
• Manufacturer (Section G): BIOHORIZONS INC.; 2300 riverchase center; birmingham AL 35253
• Manufacturer Contact: anissa smith ; 2300 riverchase center; birmingham, AL 35253
• MDR Report Key: 18946775
• Report Number: 3003631996-2024-00065
• Device Sequence Number: 15430229
• Product Code: DZE
• UDI-Device Identifier: D742MDL2513
• UDI-Public: D742MDL2513
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K070601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 02/09/2024

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 Expiration Date: 07/15/2026
• Device Model Number: MDL2513
• Device Catalogue Number: MDL2513
• Device Lot Number: 2104724
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2021
• 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