MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY GOLD/PLASTIC ENGAGING ABUTMENT; DENTAL IMPLANT

Catalog Number	8530-40
Medical Device Problem Code	Component or Accessory Incompatibility (2897)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's identifier, age, sex, weight, date of event, other relevant history, including preexisting medical conditions were not provided.Implanted & explanted dates are unknown.When the requested information becomes available, a supplementary report will be submitted.
Event or Problem Description
Per (b)(4), there was a product fit at the abutment.

• Brand Name: LEGACY GOLD/PLASTIC ENGAGING 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: 11862631
• Report Number: 3001617766-2021-02958
• Device Sequence Number: 16942380
• Product Code: NHA
• UDI-Device Identifier: 10841307111061
• UDI-Public: 10841307111061
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K090234
• 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: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 05/21/2021

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: 02/08/2026
• Device Catalogue Number: 8530-40
• Device Lot Number: 175566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1