MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC COMPLETE SURGICAL TRAY; DENTAL IMPLANT

Catalog Number	CST
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant and explant dates were not provided.If the requested information becomes available, a supplementary report will be submitted.Patient weight is unknown 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, there was a broken/fractured component.
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.

• Brand Name: COMPLETE SURGICAL TRAY
• 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: 14403630
• Report Number: 3001617766-2022-02425
• Device Sequence Number: 5527523
• Product Code: KCT
• UDI-Device Identifier: 10841307117537
• UDI-Public: 10841307117537
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K142519
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/25/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/19/2021
• Device Catalogue Number: CST
• Device Lot Number: 87072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2022
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 05/14/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2016
• 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: 46 YR
• Patient Sex: Female