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

Catalog Number	8045-31-XX
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information, implant date and explant date are not applicable as no patient is involved.Device evaluation results are not available.When the analysis is complete, a supplemental report will be submitted.
Event or Problem Description
Per (b)(4), before clinical procedure, product deformity was noticed.

• 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: 10600222
• Report Number: 3001617766-2020-06820
• Device Sequence Number: 3311689
• Product Code: NHA
• UDI-Device Identifier: 10841307116851
• UDI-Public: 10841307116851
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K192218
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Catalogue Number: 8045-31-XX
• Device Lot Number: 168651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1