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

Model Number	HLA3-5
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/22/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: LEGACY LAB ABUTMENT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e. hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 6549890
• Report Number: 3001617766-2017-00001
• Device Sequence Number: 19125195
• Product Code: NHA
• UDI-Device Identifier: 10841307111832
• UDI-Public: 10841307111832
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/21/2017

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
• Operator of Device: Health Professional
• Device Model Number: HLA3-5
• Device Catalogue Number: HLA3-5
• Device Lot Number: 89103, 83493, 78986
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2017
• Initial Report FDA Received Date: 05/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1