MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 2 IMPLANT; DENTAL IMPLANT

Catalog Number 827010

Device Problems Inadequacy of Device Shape and/or Size (1583); Positioning Problem (3009)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 04/21/2021

Event Type  Injury  

Manufacturer Narrative

Other relevant history, including preexisting medical conditions were not provided.When the requested information becomes available, a supplementary report will be submitted.

Event Description

Per complaint (b)(4), during clinical procedure, patient experienced lack of primary stability.

• Brand Name: LEGACY 2 IMPLANT
• 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: 11840823
• MDR Text Key: 251131959
• Report Number: 3001617766-2021-02638
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307101550
• UDI-Public: 10841307101550
• 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 faci
• Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 05/17/2021

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: 827010
• Device Lot Number: 175662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2021
• Initial Date FDA Received: 05/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2021
• 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: 55 YR
• Patient Weight: 66