MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC HT 2.7; HEX TOOL

Catalog Number	HT2.7
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Codes	Failure of Implant (1924); No Information (3190)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Per complaint (b)(4), a hex tool was stuck to a patient's dental implant.No adverse patient consequences were reported.
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.

• Brand Name: HT 2.7
• Common Device Name: HEX TOOL
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 8530205
• Report Number: 3001617766-2019-00168
• Device Sequence Number: 13916373
• Product Code: NDP
• UDI-Device Identifier: 10841307119647
• UDI-Public: 10841307119647
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2019

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 Expiration Date: 10/25/2023
• Device Catalogue Number: HT2.7
• Device Lot Number: 127081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 05/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1