MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC 2.5MMD HEX TOOL - LONG HT2.5

Model Number	HT2.5
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/15/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Per complaint no.(b)(4), complainant reported that during hand tightening with ratchet during implant placement, driver became stuck in implant and implant came out of osteotomy.Contraindications include smoking and the patient was (b)(6) years of age.This is a supplemental report to 3001617766-2018-00044 which captured the potentially malfunctioning dental implant reported in this incident in complaint no.(b)(4).This report captures the complaint against a potentially malfunctioning hex tool used during the failed osteomotomy.
Additional Manufacturer Narrative
Corrected for hex tool information.Relevant to implant at time of malfunction.Updated for to current information.

• Brand Name: 2.5MMD HEX TOOL - LONG HT2.5
• Common Device Name: HEX TOOL
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 7340173
• Report Number: 3001617766-2018-00045
• Device Sequence Number: 13638011
• Product Code: NDP
• UDI-Device Identifier: 10841307119630
• UDI-Public: 10841307119630
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection,Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2018

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?: Yes
• Operator of Device: Dentist
• Device Model Number: HT2.5
• Device Catalogue Number: HT2.5
• Device Lot Number: 89315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/16/2018
• Supplement Date Received by Manufacturer: 02/16/2018
• Initial Report FDA Received Date: 03/14/2018
• Supplement Report FDA Received Date: 07/02/2018
• 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: 62 YR