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

Catalog Number HT2.0SG

Device Problem Separation Failure (2547)

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

Event Date 06/26/2020

Event Type  malfunction  

Manufacturer Narrative

Customer will be contacted, pma/510k 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

Updated report submission date, contact information, awareness date of new information, report type and the device was not received for analysis.This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within (b)(4).

Manufacturer Narrative

Section b5 event or problem description corrected.

Event Description

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

• Brand Name: HEX WRENCH IMPLANT DRIVER
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks, ca
• MDR Report Key: 10398472
• MDR Text Key: 202618421
• Report Number: 3001617766-2020-06114
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307119821
• UDI-Public: 10841307119821
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2021

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 Catalogue Number: HT2.0SG
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/16/2020
• Initial Date FDA Received: 08/12/2020
• Supplement Dates Manufacturer Received: 07/16/2020; 04/20/2021
• Supplement Dates FDA Received: 08/12/2020; 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 77