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

Model Number	433011-M
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Pain (1994)
Date of Event	09/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per complaint (b)(4), during clinical procedure, patient experienced loss or failure of implant to integrate.
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.Updated a1 for patient information to include ni for no information available.Updated section b4 for report submission date and b6 to report device evaluation results.Updated g1-g2 for follow-up report submitter, g4 for awareness date and g7 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.This report is submitted late and is captured within capa - (b)(4).

• Brand Name: GODIRECT MINI 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: 9351912
• Report Number: 3001617766-2019-05250
• Device Sequence Number: 2219458
• Product Code: DZE
• UDI-Device Identifier: 10841307100256
• UDI-Public: 10841307100256
• Combination Product (Y/N): N
• Initial Reporter Country: BU
• PMA/510(K) Number: K090234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2020

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: 11/17/2018
• Device Model Number: 433011-M
• Device Catalogue Number: 433011-M
• Device Lot Number: 44688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 02/28/2020
• 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: 42 YR