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

Catalog Number HT2.3LG

Device Problem Separation Failure (2547)

Patient Problems Failure of Implant (1924); No Consequences Or Impact To Patient (2199)

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

Device not implanted.Pma/510k is not applicable.

Event Description

As per (b)(4) during a clinical procedure a dental implants components could not be separated and the implant was removed.There was 1 patient involved in this event.

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.This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within deviation 1412.

• Brand Name: DRIVER
• Type of Device: DENTAL ACCESSORY
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks, ca
• MDR Report Key: 10351118
• MDR Text Key: 201544258
• Report Number: 3001617766-2020-05396
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307119838
• UDI-Public: 10841307119838
• 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: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2022
• Device Catalogue Number: HT2.3LG
• Device Lot Number: 89347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/31/2020
• Supplement Dates Manufacturer Received: 08/07/2020
• Supplement Dates FDA Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 68