MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLY LEGACY2 IMPLANT; DENTAL IMPLANT

Catalog Number 824210U

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

Patient Problems Wound Dehiscence (1154); Bone Fracture(s) (1870); Failure of Implant (1924)

Event Date 05/11/2023

Event Type  Injury  

Manufacturer Narrative

Implant date is not applicable since product was never placed device evaluation results are not available.If the analysis is complete, a supplemental report will be submitted.

Event Description

Per complaint (b)(4), during clinical procedure, bone fracture was observed.

Manufacturer Narrative

Follow-up submitted for additional information.

• Brand Name: SIMPLY LEGACY2 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: 17037400
• MDR Text Key: 316288785
• Report Number: 3001617766-2023-02349
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307107408
• UDI-Public: 10841307107408
• 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 Facility
• Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 824210U
• Device Lot Number: 15004341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/24/2023
• 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: 47 YR
• Patient Sex: Female
• Patient Weight: 61 KG