HEX TOOL HT2.5

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-05 for HEX TOOL HT2.5 manufactured by Implant Direct Sybron Manufacturing Llc.

Event Text Entries

[186540865] Patient identifier, age, sex, date of event and pma/510k are unknown.
Patient Sequence No: 1, Text Type: N, H10

[186540866] Per complaint (b)(4), components could not be separated. There was no patient impact noted.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3001617766-2020-00592
• MDR Report Key: 9793628
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2020-03-05
• Date of Report: 2020-03-05
• Date Mfgr Received: 2020-02-27
• Device Manufacturer Date: 2013-06-19
• Date Added to Maude: 2020-03-05
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: DENTIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MRS. KAI DIAZ
• Manufacturer Street: 3050 E HILLCREST DR.
• Manufacturer City: THOUSAND OAKS, CA
• Manufacturer Country: US
• Manufacturer Phone: 4443300353
• Single Use: 3
• Remedial Action: IN
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HEX TOOL
• Generic Name: DENTAL HEX TOOL
• Product Code: NDP
• Date Received: 2020-03-05
• Model Number: HT2.5
• Catalog Number: HT2.5
• Lot Number: 43952
• Device Expiration Date: 2018-06-18
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: IMPLANT DIRECT SYBRON MANUFACTURING LLC
• Manufacturer Address: 3050 E HILLCREST DR. THOUSAND OAKS, CA US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-03-05