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

Catalog Number	864213
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure of Implant (1924); Numbness (2415)
Date of Event	09/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per complaint (b)(4), the patient stated that they felt numb.The doctor noted possible nerve impingement with implant approximately to the inferior alveolar.The implant was extracted.

• Brand Name: LEGACY 3 IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 8085550
• Report Number: 3001617766-2018-00321
• Device Sequence Number: 19424247
• Product Code: DZE
• UDI-Device Identifier: 10841307102533
• UDI-Public: 10841307102533
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K090234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 11/19/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 864213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR