MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLYFIXED LEGACY SMART PACK; DENTAL IMPLANT ABUTMENT

Model Number 8045-64-15SK

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Doctor reports three out of six ordered legacy dentistry smart packs were received opened and missing parts with writing on label.This was identified before use.There was no patient involvement.There have been no other reported events for this part and lot number.

• Brand Name: SIMPLYFIXED LEGACY SMART PACK
• Type of Device: DENTAL IMPLANT ABUTMENT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer (Section G): 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: 7528192
• MDR Text Key: 108734479
• Report Number: 3001617766-2018-00122
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 10841307117841
• UDI-Public: 10841307117841
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 06/18/2018

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: Dentist
• Device Expiration Date: 11/19/2020
• Device Model Number: 8045-64-15SK
• Device Catalogue Number: 8045-64-15SK
• Device Lot Number: 71239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/18/2018
• Supplement Dates Manufacturer Received: 04/19/2018
• Supplement Dates FDA Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/20/2015
• 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