MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY FULL-CONTOUR ABUTMENT 3.5MMD ASSEMBLY; LEGACY LAB ABUTMENT

Model Number HLA3-5

Device Problem Nonstandard Device (1420)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/22/2017

Event Type  malfunction  

Manufacturer Narrative

The devices that are in possession of the initial reporter has not been returned yet.Instead, a lot check was performed per inspection level ii acceptable quality limit (aql) 1.0 and the initial reporter's complaint was confirmed.Device was not returned.

Event Description

The hla3-5 legacy lab abutment unique identifier assigned: hhe hla3-5rev01 was out of implant direct specifications, there was one raw stock manufactured and affected and the lot was placed into 3 finished goods lots.

• Brand Name: LEGACY FULL-CONTOUR ABUTMENT 3.5MMD ASSEMBLY
• Type of Device: LEGACY LAB ABUTMENT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e. hillcrest drive; thousand oaks CA 91362
• Manufacturer (Section G): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e. hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: leo meza ; 3050 e. hillcrest drive; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 6549890
• MDR Text Key: 74741698
• Report Number: 3001617766-2017-00001
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 10841307111832
• UDI-Public: 10841307111832
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HLA3-5
• Device Catalogue Number: HLA3-5
• Device Lot Number: 89103, 83493, 78986
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/16/2016
• 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