MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLYFIXED LEGACY¿ ANGLED; DENTAL ABUTMENT

Catalog Number 8045-64-15SK

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Original complaint submitted 05/18/2018.Maude report ran on 06/19/2018 shows no record of complaint number.Submitting as initial report again within follow-up time frame for new information.

Event Description

Per the complaint, product received open, missing parts with writing on label.There is no patient impact as it was discovered before use.

• Brand Name: SIMPLYFIXED LEGACY¿ ANGLED
• Type of Device: DENTAL ABUTMENT
• 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: 7623494
• MDR Text Key: 112037601
• Report Number: 3001617766-2018-00123
• 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
• Report Date: 06/20/2018

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 Catalogue Number: 8045-64-15SK
• Device Lot Number: 71239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• 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: 06/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1