MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 4 IMPLANT; DENTAL IMPLANT

Catalog Number 883711

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); No Consequences Or Impact To Patient (2199)

Event Date 05/19/2019

Event Type  Injury  

Event Description

Per complaint (b)(4), it was reported that a patient's dental crown had come off.It was discovered through a periapical radiograph that the patient had a broken abutment and dental implant.The implant could not be saved due to the damage.The implant was removed and will be replaced once the area is healed.

• Brand Name: LEGACY 4 IMPLANT
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest dr.; thousand oaks CA 91362
• Manufacturer Contact: monica roche ; 3050 east hillcrest dr.; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 8722915
• MDR Text Key: 148792718
• Report Number: 3001617766-2019-00284
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307103264
• UDI-Public: 10841307103264
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090234
• 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: 06/21/2019

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 Expiration Date: 04/30/2020
• Device Catalogue Number: 883711
• Device Lot Number: 63241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 06/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• 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: 72 YR