MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY OVERDENTURE ABUTMENT

Model Number	8045-61
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the complaint, (b)(4) distributor reports the dental implant abutment was broken one year after fixation, causing a removal of the implant.This is a reportable serious injury.

• Brand Name: LEGACY OVERDENTURE ABUTMENT
• Common Device Name: OVERDENTURE ABUTMENT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 7507647
• Report Number: 3001617766-2018-00114
• Device Sequence Number: 13971496
• Product Code: NHA
• UDI-Device Identifier: 10841307111511
• UDI-Public: 10841307111511
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2018

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: 8045-61
• Device Catalogue Number: 8045-61
• Device Lot Number: 72976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 05/11/2018
• 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: Other