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

Catalog Number HT2.0LG

Device Problem Defective Device (2588)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/08/2023

Event Type  Injury  

Manufacturer Narrative

Patient weight is unknown.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, broken or fractured component was observed.

Manufacturer Narrative

Follow-up submitted to report device evaluation.Updated section b4 for report submission date and b6 to report device evaluation results.Updated g1 for follow-up report submitter, g3 for awareness date and g6 for report type and follow-up number.Updated h2 for follow-up type, h3 for device evaluation status and h6 method, result and conclusion codes.

• 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: 16857035
• MDR Text Key: 314436628
• Report Number: 3001617766-2023-01865
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307119814
• UDI-Public: 10841307119814
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• 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,Followup
• Report Date: 07/31/2023

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: HT2.0LG
• Device Lot Number: 192862
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 07/05/2023
• Supplement Dates FDA Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2021
• 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: 52 YR
• Patient Sex: Male