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

Catalog Number	HT2.0SG
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Codes	Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer will be contacted, pma/510k not applicable.
Event or Problem 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.
Additional 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).
Additional Manufacturer Narrative
Section b5 event or problem description corrected.
Event or Problem 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
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks, ca
• MDR Report Key: 10398472
• Report Number: 3001617766-2020-06114
• Device Sequence Number: 2671153
• Product Code: NDP
• UDI-Device Identifier: 10841307119821
• UDI-Public: 10841307119821
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: HT2.0SG
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 07/16/2020; 04/20/2021
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 08/12/2020; 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 77