MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC GUIDED SURGERY HANDLE INSERT 2.3MMD; GUIDED SURGERY INSERT

Model Number GS-2.3

Device Problem Device-Device Incompatibility (2919)

Patient Problems Failure of Implant (1924); No Information (3190)

Event Date 12/20/2017

Event Type  Injury  

Event Description

While doing guided surgery the doctor found the drills wouldn't move through the inserts past were the narrow apex meets the wider part of drill.Because doctor had to skip drill in the sequence they couldn't get the correct size osteotomy and the implant couldn't achieve stability.This is a reportable serious injury and device malfunction, requiring second surgery to complete the procedure.

• Brand Name: GUIDED SURGERY HANDLE INSERT 2.3MMD
• Type of Device: GUIDED SURGERY INSERT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer (Section G): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: lia meshwork ; 3050 east hillcrest drive; thousand oaks, CA 91362
• MDR Report Key: 7493105
• MDR Text Key: 107561329
• Report Number: 3001617766-2018-00092
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307122586
• UDI-Public: 10841307122586
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 05/01/2016
• Device Model Number: GS-2.3
• Device Catalogue Number: GS-2.3
• Device Lot Number: 105440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention