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

Catalog Number	SD3.4
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Per complaint (b)(4), during clinical procedure, components could not be separated.
Additional Manufacturer Narrative
Explant date is not applicable since product was not removed.Device evaluation results are not available.If the analysis is complete, a supplemental report will be submitted.

• Brand Name: STEP DRILL (6-16MML)
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: sergio alvarado ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8057785975
• MDR Report Key: 16712835
• Report Number: 3001617766-2023-01511
• Device Sequence Number: 17957904
• Product Code: DZI
• UDI-Device Identifier: 10841307117162
• UDI-Public: 10841307117162
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K081396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 04/11/2023

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: SD3.4
• Device Lot Number: 209381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 86 KG