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

Catalog Number	1037-61
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	10/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Per complaint (b)(4), there was a fracture on a multi-unit abutment four months after initial placement of a patient's dental implant.The abutment was removed.
Additional Manufacturer Narrative
Corrected event type from serious injury to malfunction.
Event or Problem Description
Per complaint (b)(4), there was a fracture on a multi-unit abutment four months after initial placement of a patient's dental implant.The abutment was removed.
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.(b)(4).

• Brand Name: OVERDENTURE ABUTMENT
• Common Device Name: DENTAL ABUTMENT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e. hillcrest dr.; thousand oaks CA 91362
• MDR Report Key: 8167746
• Report Number: 3001617766-2018-00378
• Device Sequence Number: 19304718
• Product Code: NHA
• UDI-Device Identifier: 10841307114857
• UDI-Public: 10841307114857
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K061319
• 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,Followup,Followup
• Report Date (Section B): 02/12/2019

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: Health Professional
• Device Expiration Date: 10/19/2020
• Device Catalogue Number: 1037-61
• Device Lot Number: 69602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 11/16/2018; 01/17/2019
• Initial Report FDA Received Date: 12/15/2018
• Supplement Report FDA Received Date: 12/16/2018; 02/12/2019
• 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: 64 YR