MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC REPLANT LABORATORY TOOL; DENTAL IMPLANT

Model Number 6035-07

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Information (3190)

Event Date 01/22/2020

Event Type  malfunction  

Event Description

Per complaint (b)(4), during inventory check, labeling issue was identified.

Manufacturer Narrative

Follow-up submitted to report device evaluation.Updated section b3 for event date, section b4 for report submission date and b6 to report device evaluation results.Updated g1-g2 for follow-up report submitter, g4 for awareness date and g7 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.Sections a, b7, d6, d7, g5 are not applicable.

• Brand Name: REPLANT LABORATORY TOOL
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks, ca
• MDR Report Key: 9725504
• MDR Text Key: 180121261
• Report Number: 3001617766-2020-01666
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307119296
• UDI-Public: 10841307119296
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: 6035-07
• Device Catalogue Number: 6035-07
• Device Lot Number: 68415
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/22/2020
• Initial Date FDA Received: 02/19/2020
• Supplement Dates Manufacturer Received: 03/23/2020
• Supplement Dates FDA Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention