MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 2 IMPLANT; DENTAL IMPLANT

Catalog Number 825210

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem Failure of Implant (1924)

Event Date 08/22/2020

Event Type  Injury  

Manufacturer Narrative

Patient's weight was not provided.When the requested information becomes available, a supplementary report will be submitted.Device evaluation results are not available.When the analysis is complete, a supplemental report will be submitted.(b)(4).

Event Description

Per complaint (b)(4), during the clinical procedure, driver would not engage the implant and would not rotate.Therefore, another implant was used.

• Brand Name: LEGACY 2 IMPLANT
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: douglas wilkin ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 6614818356
• MDR Report Key: 10600164
• MDR Text Key: 208967868
• Report Number: 3001617766-2020-06769
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307101437
• UDI-Public: 10841307101437
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192221
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 825210
• Device Lot Number: 165417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR