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

Catalog Number TI250PL-1

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 12/19/2019

Event Type  malfunction  

Event Description

Per complaint (b)(4), at distribution it was discovered that a product over-label contained the incorrect lot number.

• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: adrienne stott ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 9602957
• MDR Text Key: 180112649
• Report Number: 3001617766-2020-00451
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 01/17/2020

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 Catalogue Number: TI250PL-1
• Device Lot Number: 13400100000069
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 01/17/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/17/2019
• 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