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

Model Number	423010L
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event	09/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per complaint (b)(4), during clinical procedure, buccal plate got fractured during implant insertion.
Additional Manufacturer Narrative
Follow-up submitted to correct date of this report in date of report.
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.Updated section b4 for report submission date and b6 to report device evaluation results.Updated d9 for device return date, g1 for follow-up report submitter, g3 for awareness date and g6 for report type and follow-up number.Updated h2 for follow-up type, h3 for device evaluation status and h6 method, result and conclusion codes.When information becomes available, a supplemental report will be filed.This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within deviation 1412.

• 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
• MDR Report Key: 9214518
• Report Number: 3001617766-2019-04542
• Device Sequence Number: 13557739
• Product Code: DZE
• UDI-Device Identifier: 10841307121985
• UDI-Public: 10841307121985
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K090234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/19/2021

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: 08/19/2024
• Device Model Number: 423010L
• Device Catalogue Number: 423010L
• Device Lot Number: 149265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 09/26/2019; 10/23/2019
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 10/23/2019; 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR