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

Catalog Number	803711
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Per compliant (b)(4), during clinical procedure, dropped from implant driver.
Additional Manufacturer Narrative
Implant and explant dates were not provided.If the requested information becomes available, a supplementary report will be submitted.Patient weight and bone quality are unknown device evaluation results are not available.If the analysis is complete, a supplemental report will be submitted.

• 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: 17300379
• Report Number: 3001617766-2023-02969
• Device Sequence Number: 7061328
• Product Code: DZE
• UDI-Device Identifier: 10841307100805
• UDI-Public: 10841307100805
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K061319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/11/2023

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: 08/01/2023
• Device Catalogue Number: 803711
• Device Lot Number: 120581
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2018
• 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: 35 YR
• Patient Sex: Female