MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 3 IMPLANT; DENTAL IMPLANT

Catalog Number 853710

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)

Event Date 07/24/2019

Event Type  Injury  

Event Description

Per complaint (b)(4), a dental abutment fractured during clinical procedure.Primary stability could not be achieved.The implant was removed and replaced with a different one within the same visit.Osteopenia was also reported.

Manufacturer Narrative

Follow-up submitted to report device evaluation.

• Brand Name: LEGACY 3 IMPLANT
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 9073962
• MDR Text Key: 161348617
• Report Number: 3001617766-2019-02310
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307102052
• UDI-Public: 10841307102052
• Combination Product (y/n): N
• PMA/PMN Number: K090234
• 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,Followup
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2024
• Device Catalogue Number: 853710
• Device Lot Number: 142133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Initial Date Manufacturer Received: 08/17/2019
• Initial Date FDA Received: 09/16/2019
• Supplement Dates Manufacturer Received: 09/20/2019
• Supplement Dates FDA Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR