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

Catalog Number HD2.3SG

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Failure of Implant (1924)

Event Date 08/24/2021

Event Type  malfunction  

Manufacturer Narrative

Patient's identifier, sex, other relevant history, including preexisting medical conditions and explant date were not provided.If the requested information becomes available, a supplementary report will be submitted.Patient age and weight are unknown.Device evaluation results are not available.If the analysis is complete, a supplemental report will be submitted.Pma/510(k) - not applicable.

Event Description

Per complaint (b)(4), before clinical procedure, labeling issue was observed.

Manufacturer Narrative

Follow-up submitted to report device evaluation.Updated section b4 for report submission date and b6 to report device evaluation results.Updated d9 for device return 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, h3 for device evaluation status and h6 method, result and conclusion codes.

• Brand Name: SIMPLYINTERACTIVE DRIVER
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 12391034
• MDR Text Key: 268895421
• Report Number: 3001617766-2021-05114
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307119920
• UDI-Public: 10841307119920
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HD2.3SG
• Device Lot Number: 188311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Date Manufacturer Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1