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

Model Number	HT2.5LG
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Per complaint (b)(4), the ht2.5 tool became stuck in the implant.This resulted in the removal of the implant.
Additional Manufacturer Narrative
No information was able to be obtainined for the following sections: a1, a4, d4 lot number and expiration date, and h5 - device manufacture date.Updated: b5, h5, h6: method, result and conclusion code.Correction: d4- cataloge and udi number, d6, d7, g5, h4, h5 previously reported implant date, explant date and device manufacture date do not apply.Additional information regarding the complaint was requested for verification, however no additional information is available as the clinician is no longer practicing.
Event or Problem Description
Per complaint 42443, during a dental implant clinical procedure a hex tool became stuck within the implant.The clinician first inserted the implant with the 2.5 tool, removed the tool and proceeded with ht2.0sg which became stuck within the implant.

• Brand Name: SIMPLYLEGACY DRIVER
• Common Device Name: WRENCH
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 7801814
• Report Number: 3001617766-2018-00201
• Device Sequence Number: 16771232
• Product Code: NDP
• UDI-Device Identifier: 10841307119852
• UDI-Public: 10841307119852
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K090234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2020

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 Model Number: HT2.5LG
• Device Catalogue Number: HT2.0SG
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR