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

Catalog Number SD3.4

Device Problem Separation Failure (2547)

Patient Problem Insufficient Information (4580)

Event Date 03/24/2023

Event Type  Injury  

Event Description

Per complaint (b)(4), during clinical procedure, components could not be separated.

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)
• Type of Device: 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
• MDR Text Key: 313021698
• Report Number: 3001617766-2023-01511
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 10841307117162
• UDI-Public: 10841307117162
• 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 Facility
• Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/25/2022
• 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
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 86 KG