MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC STEP DRILL (6-16MML); DENTAL IMPLANT

Catalog Number SD2.8

Device Problem Separation Failure (2547)

Patient Problems Failure of Implant (1924); No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Per complaint (b)(4), during clinical procedure it was observed that the components could not be separated.

• Brand Name: STEP DRILL (6-16MML)
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: adrienne stott ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 9283247
• MDR Text Key: 165218884
• Report Number: 3001617766-2019-04962
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 10841307117155
• UDI-Public: 10841307117155
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD2.8
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2019
• Was Device Evaluated by Manufacturer?: No
• 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