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

Model Number 6534-63-15SK

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems Failure of Implant (1924); No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Information was not provided and if it becomes available, a follow-up report will be submitted.

Event Description

Per complaint (b)(4), within distribution warehouse- ncmr was created because the label was peeling off the abutment kit.

• Brand Name: SIMPLYFIXED INTERACTIVE ANGLED
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks, ca
• Manufacturer Contact: adrienne stott ; 3050 east hillcrest drive; thousand oaks, ca ; 4443300357
• MDR Report Key: 9859251
• MDR Text Key: 184279226
• Report Number: 3001617766-2020-02894
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 10841307117681
• UDI-Public: 10841307117681
• 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,user faci
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2021
• Device Model Number: 6534-63-15SK
• Device Catalogue Number: 6534-63-15SK
• Device Lot Number: 75331
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/18/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/03/2016
• 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