MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLYLEGACY2 IMPLANT; DENTAL IMPLANT

Catalog Number	825213U
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant date, explant date not applicable as implant was not placed.
Event or Problem Description
As per (b)(4) during a clinical procedure a dental implant displayed a lack of primary stability and the implant was removed.There was 1 patient involved in this event.
Additional Manufacturer Narrative
Updated b4 for report submission date, g1 for contact information, g3 for awareness date of new information, g6 for report type and h6 to report that the device was not received for analysis.This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within deviation 1412.

• Brand Name: SIMPLYLEGACY2 IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks, ca
• MDR Report Key: 10311340
• Report Number: 3001617766-2020-05351
• Device Sequence Number: 10968900
• Product Code: DZE
• UDI-Device Identifier: 10841307107521
• UDI-Public: 10841307107521
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician Assistant
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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: 05/31/2023
• Device Catalogue Number: 825213U
• Device Lot Number: 116618
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 06/02/2021
• 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: 71 YR
• Patient Weight: 95