MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC GODIRECT IMPLANT; DENTAL IMPLANT

Catalog Number	423710L
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Fibrosis (3167)
Date of Event	09/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation results are not available.If the analysis is complete, a supplemental report will be submitted.
Event or Problem Description
Per (b)(4), after clinical procedure, patient experienced failure of implant to osseointegrate.
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.

• Brand Name: GODIRECT IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: karen manalili ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8057785914
• MDR Report Key: 12582091
• Report Number: 3001617766-2021-05857
• Device Sequence Number: 17084496
• Product Code: DZE
• UDI-Device Identifier: 10841307122074
• UDI-Public: 10841307122074
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K090234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2021

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: 02/10/2026
• Device Catalogue Number: 423710L
• Device Lot Number: 177922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2021
• 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 Age: 31 YR
• Patient Sex: Female
• Patient Weight: 59 KG