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

Catalog Number HT2.0SG

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Discomfort (2330)

Event Date 01/20/2023

Event Type  Injury  

Event Description

Per complaint (b)(4) during clinical procedure, broken/fractured component was observed.

Manufacturer Narrative

Explant date is not applicable since the product was not removed.Patient weight is unknown.Lot information is unknown.If additional information becomes available a supplementary report will be submitted.Device evaluation results are not available.If the analysis is complete, a supplemental report will be submitted.

• Brand Name: SIMPLYLEGACY DRIVER
• 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: 16377862
• MDR Text Key: 309552243
• Report Number: 3001617766-2023-00550
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307119821
• UDI-Public: 10841307119821
• 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: 02/15/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HT2.0SG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2023
• Initial Date FDA Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: No
• 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: 46 YR
• Patient Sex: Female