MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY IMPLANT OPEN-TRAY TRANSFER-CONCAVE PROFILE NON-ENGAGING; DENTAL IMPLANT

Catalog Number 8730-08NE

Device Problem Positioning Failure (1158)

Patient Problem Failure of Implant (1924)

Event Date 02/22/2023

Event Type  Injury  

Event Description

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

Manufacturer Narrative

Device evaluation results are not available.If the analysis is complete, a supplemental report will be submitted.

• Brand Name: LEGACY IMPLANT OPEN-TRAY TRANSFER-CONCAVE PROFILE NON-ENGAGING
• 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: 17247798
• MDR Text Key: 318289652
• Report Number: 3001617766-2023-02880
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307121633
• UDI-Public: 10841307121633
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 07/03/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 8730-08NE
• Device Lot Number: 163058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 07/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2020
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 68 KG