MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC 2.5MMD HEX TOOL - SHORT; DENTAL IMPLANT

Model Number	HT2.5S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Osteopenia/ Osteoporosis (2651); No Code Available (3191)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drivers stuck to implant and required so much force to disengage that it removed implant & couldn't be engaged again.Implant was removed and a second surgery was required.This is a reportable serious injury.

• Brand Name: 2.5MMD HEX TOOL - SHORT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 7474594
• Report Number: 3001617766-2018-00082
• Device Sequence Number: 19095611
• Product Code: DZE
• UDI-Device Identifier: 10841307119708
• UDI-Public: 10841307119708
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 04/30/2018

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: Dentist
• Device Model Number: HT2.5S
• Device Catalogue Number: HT2.5S
• Device Lot Number: 109592
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2018
• Initial Report FDA Received Date: 04/30/2018
• 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: 69 YR