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

Catalog Number ICST

Device Problem Osseointegration Problem (3003)

Patient Problems Failure of Implant (1924); Inflammation (1932); Pain (1994)

Event Date 01/04/2021

Event Type  Injury  

Manufacturer Narrative

Patient's weight was 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 Description

Per complaint (b)(4), after clinical procedure, patient experienced failure of implant to osseointegrate.

Manufacturer Narrative

Re-evaluation for reportability concludes that this event is not likely to cause or contribute to death, serious injury, or serious deterioration in health.Therefore, this complaint is non-reportable to the fda.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.

• Brand Name: INTERACTIVE 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: 12503684
• MDR Text Key: 272420589
• Report Number: 3001617766-2021-05433
• Device Sequence Number: 1
• Product Code: KCT
• UDI-Device Identifier: 10841307117551
• UDI-Public: 10841307117551
• 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: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ICST
• Device Lot Number: 166958
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/03/2020
• 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: 67 YR
• Patient Sex: Female