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

Catalog Number HT2.5LG

Device Problem Osseointegration Problem (3003)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

Patient's identifier, date of event and explant date were not provided.When the requested information becomes available, a supplementary report will be submitted.Patient weight is unknown.Pma/510(k) - not applicable.

Event Description

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

• 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: karen manalili ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8057785914
• MDR Report Key: 11877189
• MDR Text Key: 252414841
• Report Number: 3001617766-2021-03006
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307119852
• UDI-Public: 10841307119852
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HT2.5LG
• Device Lot Number: 162591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Date Manufacturer Received: 04/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2020
• 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 Age: 68 YR