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

Catalog Number SD3.4

Device Problem Component or Accessory Incompatibility (2897)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 04/05/2023

Event Type  Injury  

Manufacturer Narrative

Implant and explant dates are not applicable sine product was never placed and not removed device evaluation results are not available.If the analysis is complete, a supplemental report will be submitted.

Event Description

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

Manufacturer Narrative

Follow-up submitted to report device evaluation.Updated section b4 for report submission date and b6 to report device evaluation results.Updated d9 for device return date, g1 for follow-up report submitter, g3 for awareness date and g6 for report type and follow-up number.Updated h2 for follow-up type, h3 for device evaluation status and h6 method, result and conclusion codes.

• 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: 16767729
• MDR Text Key: 313559458
• Report Number: 3001617766-2023-01666
• 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,Followup
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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 Sex: Female
• Patient Weight: 72 KG