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

Model Number	423013
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per complaint (b)(4), patient experienced lack of primary stability.
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.Updated a1 for patient information and b7 for other relevent history 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-1374.

• 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: 9351915
• Report Number: 3001617766-2019-05228
• Device Sequence Number: 2402916
• Product Code: DZE
• UDI-Device Identifier: 10841307100041
• UDI-Public: 10841307100041
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: 08/07/2019
• Device Model Number: 423013
• Device Catalogue Number: 423013
• Device Lot Number: 54275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• 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