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

Catalog Number CST

Device Problem Material Deformation (2976)

Patient Problem Failure of Implant (1924)

Event Date 05/05/2022

Event Type  Injury  

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 Description

Per complaint (b)(4), during clinical procedure, there was a broken/fractured component.

Manufacturer Narrative

Follow-up submitted to report device evaluation.

• Brand Name: COMPLETE SURGICAL TRAY
• Type of Device: 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: 14403625
• MDR Text Key: 291720830
• Report Number: 3001617766-2022-02424
• Device Sequence Number: 1
• Product Code: KCT
• UDI-Device Identifier: 10841307117537
• UDI-Public: 10841307117537
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142519
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female