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

Model Number	6035-07
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Per complaint (b)(4), during inventory check, labeling issue was identified.
Additional 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
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks, ca
• MDR Report Key: 9725504
• Report Number: 3001617766-2020-01666
• Device Sequence Number: 19447979
• Product Code: NDP
• UDI-Device Identifier: 10841307119296
• UDI-Public: 10841307119296
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 05/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention