MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC CUSTOM LEGACY TITANIUM ABUTMENT; DENTAL IMPLANT

Model Number	8035-31-XX
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932)
Date of Event	01/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Per complaint (b)(4), after clinical procedure, the component got fractured.
Additional Manufacturer Narrative
Updated b4 for report submission date, g1 for contact information, g3 for awareness date of new information, g6 for report type and sections d9, h1, h2, h3, and h6 to report that the device was not received for analysis.When information becomes available, a supplemental report will be filed.This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within deviation 1412.

• Brand Name: CUSTOM LEGACY TITANIUM ABUTMENT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 9646106
• Report Number: 3001617766-2020-01138
• Device Sequence Number: 10857518
• Product Code: NHA
• UDI-Device Identifier: 10841307116844
• UDI-Public: 10841307116844
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K061319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2021

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: 01/27/2024
• Device Model Number: 8035-31-XX
• Device Catalogue Number: 8035-31-XX
• Device Lot Number: 133694
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 06/11/2021
• 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: 55 YR