MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY1 IMPLANT; DENTAL IMPLANT

Catalog Number	804711
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's identifier, age, sex, weight, other relevant history, including pre-existing medical conditions, implant date and explant date were not provided.If the requested information becomes available, a supplementary report will be submitted.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, bone fracture was observed.
Additional Manufacturer Narrative
Follow-up submitted for additional information.Updated section b4 for report submission date, g1 for follow-up report submitter, g3 for awareness date and g6 for report type and follow-up number.Updated h2 for follow-up type.Updated section a1, a2, a3, a4 & d6a for patient identifier, age, sex, weight and implant date.Date of explant is unknown.

• Brand Name: LEGACY1 IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: sergio alvarado ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8057785975
• MDR Report Key: 17010018
• Report Number: 3001617766-2023-02244
• Device Sequence Number: 20576801
• Product Code: DZE
• UDI-Device Identifier: 10841307100904
• UDI-Public: 10841307100904
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K061319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2023

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: 09/21/2024
• Device Catalogue Number: 804711
• Device Lot Number: 151606
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/02/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2019
• 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 Sex: Female
• Patient Weight: 88 KG