MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY ANGLED OVERDENTURE ABUTMENT; DENTAL IMPLANT

Catalog Number 8530-63-15S

Device Problem Loss of Osseointegration (2408)

Patient Problems Granuloma (1876); Failure of Implant (1924)

Event Date 05/07/2020

Event Type  Injury  

Manufacturer Narrative

This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within deviation 1412.

Event Description

Per complaint (b)(4), after clinical procedure, patient experienced loss of implant to osseointegrate.

• Brand Name: LEGACY ANGLED OVERDENTURE ABUTMENT
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: douglas wilkin ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 6614818356
• MDR Report Key: 10816528
• MDR Text Key: 215508461
• Report Number: 3001617766-2020-07837
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 10841307110859
• UDI-Public: 10841307110859
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143011
• 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: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2024
• Device Catalogue Number: 8530-63-15S
• Device Lot Number: 132972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2019
• 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: 57 YR
• Patient Weight: 64