MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC DRILL STOP KIT - LONG EMPTY; DENTAL IMPLANT

Catalog Number DSKL

Device Problem Corroded (1131)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

Patient's identifier, age, sex, weight, date of event, other relevant history, including preexisting medical conditions, implant date and explant date were not provided.If the requested information becomes available, a supplementary report will be submitted.Device evaluation results are not available.If the analysis is complete, a supplemental report will be submitted.

Event Description

Per complaint (b)(4), before clinical procedure, surface defect was observed.

Manufacturer Narrative

Follow-up submitted for correction.Corrected h1 for type of reportable event.Updated section b4 for report submission 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.

Manufacturer Narrative

Follow-up submitted to report device evaluation.

• Brand Name: DRILL STOP KIT - LONG EMPTY
• 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: 16815368
• MDR Text Key: 314009566
• Report Number: 3001617766-2023-01793
• Device Sequence Number: 1
• Product Code: KCT
• UDI-Device Identifier: 10841307125334
• UDI-Public: 10841307125334
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K200858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DSKL
• Device Lot Number: 15000748
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2022
• 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