MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY3 IMPLANT 4.7MMD X 8MML SBM; DENTAL IMPLANT

Model Number 854708

Device Problems Device-Device Incompatibility (2919); Human Factors Issue (2948); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Hyperplasia (1906); Failure of Implant (1924); Inflammation (1932); Nerve Damage (1979); Pain (1994); Impaired Healing (2378); Osteopenia/ Osteoporosis (2651)

Event Date 03/15/2018

Event Type  Injury  

Event Description

The dentist could not remove abutment on the implant after implantation due to excessive tight fixation with implant.Implant was removed, requiring medical intervention.

Manufacturer Narrative

Corrected date received by manufacturer, device manufacture date, and event problem and evaluation codes.

• Brand Name: LEGACY3 IMPLANT 4.7MMD X 8MML SBM
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e hillcrest drive; thousand oaks CA 91362
• Manufacturer (Section G): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: adrienne stott ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 7470855
• MDR Text Key: 106829939
• Report Number: 3001617766-2018-00079
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307102168
• UDI-Public: 10841307102168
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K090234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 06/01/2018

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: Dentist
• Device Expiration Date: 08/17/2022
• Device Model Number: 854708
• Device Catalogue Number: 854708
• Device Lot Number: 99687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2018
• Initial Date FDA Received: 04/27/2018
• Supplement Dates Manufacturer Received: 03/29/2018
• Supplement Dates FDA Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2017
• 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: 41 YR