MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY IMPLANT 5.7MMD X 13MML; DENTAL IMPLANT

Model Number	805713
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	11/23/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per complaint# (b)(4), complainant reported that patient's implant fractured 1 year after implant.Patient contraindications included bruxism and he was (b)(6) years old.

• Brand Name: LEGACY IMPLANT 5.7MMD X 13MML
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 7311685
• Report Number: 3001617766-2018-00035
• Device Sequence Number: 11088024
• Product Code: DZE
• UDI-Device Identifier: 10841307100966
• UDI-Public: 10841307100966
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K061319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/02/2018

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?: Yes
• Operator of Device: Dentist
• Device Model Number: 805713
• Device Catalogue Number: 805713
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2018
• 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: 77 YR