MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC GODIRECT® IMPLANT INSERTION DRILL

Catalog Number	GDID
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the complaint, the shaft of the instrument broke when turning.This resulted in the implant not being set to planned depth, 1-2 mm too high.

• Brand Name: GODIRECT® IMPLANT INSERTION DRILL
• Common Device Name: INSERTION DRILL
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 7701317
• Report Number: 3001617766-2018-00168
• Device Sequence Number: 1269655
• Product Code: NDP
• UDI-Device Identifier: 10841307119524
• UDI-Public: 10841307119524
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: N/A
• 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): 07/18/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: GDID
• Device Lot Number: 105088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 07/18/2018
• 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: 56 YR