MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY1 IMPLANT; DENTAL IMPLANT

Catalog Number 803710

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Failure of Implant (1924)

Event Date 06/21/2023

Event Type  Injury  

Manufacturer Narrative

Patient weight and bone quality are unknown.Device evaluation results are not available.If the analysis is complete, a supplemental report will be submitted.

Event Description

Per complaint (b)(4), after clinical procedure, product fit issue was observed.

• Brand Name: LEGACY1 IMPLANT
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: sergio alvarado ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8057785975
• MDR Report Key: 17819047
• MDR Text Key: 324282237
• Report Number: 3001617766-2023-03967
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307100799
• UDI-Public: 10841307100799
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K061319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2023
• Device Catalogue Number: 803710
• Device Lot Number: 108761
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/20/2018
• 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: 57 YR
• Patient Sex: Male