MAUDE Adverse Event Report: IMPLANT DIRECT LLC SPECTRA/LEGACY GUIDED SURGERY HANDLE KIT

Model Number	G-HK
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/25/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Drills became stuck in the guided handles during surgical procedure.This caused the osteotomy to be inaccurately drills and the implant spun due to over "preperation" cause by the guided handle malfunction.

• Brand Name: SPECTRA/LEGACY GUIDED SURGERY HANDLE KIT
• Common Device Name: GUIDED SURGERY HANDLE KIT
• Manufacturer (Section D): IMPLANT DIRECT LLC; 3050 e hillcrest dr.; thousand oaks CA 91362
• MDR Report Key: 6995239
• Report Number: 3001617766-2017-00012
• Device Sequence Number: 1006294
• Product Code: NDP
• UDI-Device Identifier: 10841307119210
• UDI-Public: 10841307119210
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Dentist
• Device Model Number: G-HK
• Device Catalogue Number: G-HK
• Device Lot Number: 87839
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2017
• Initial Report FDA Received Date: 11/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR