MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY2 IMPLANT; DENTAL IMPLANT

Catalog Number	827010
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event	09/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's weight is unknown.Explant date is not provided.Device evaluation results are not available.If the analysis is complete, a supplemental report will be submitted.
Event or Problem Description
Per complaint (b)(4), during clinical procedure, product fracture is occurred.

• Brand Name: LEGACY2 IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: karen manalili ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8057785914
• MDR Report Key: 15146468
• Report Number: 3001617766-2022-03968
• Device Sequence Number: 5464389
• Product Code: DZE
• UDI-Device Identifier: 10841307101550
• UDI-Public: 10841307101550
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K192221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 08/02/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2025
• Device Catalogue Number: 827010
• Device Lot Number: 158866
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male