MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY2 4.7DX10L 4.5MMD PLATFORM; DENTAL IMPLANT

Model Number 824710

Device Problem Device-Device Incompatibility (2919)

Patient Problem Failure of Implant (1924)

Event Date 02/22/2018

Event Type  malfunction  

Event Description

Complaint (b)(4) reports that packed cover screw is for 5.7mm platform, not a 4.5mm.Dentist stated "placing a 4.7x10 legacy2 implant.Noticed that the cover screw was too large for the implant.Opened another 4.7mm implant ot use that cover screw which was also too large." no patient impact.

Manufacturer Narrative

Qa inspection of returned product: appearance: implant received in new condition.Specification should be: length:.394 ±.003 specification as found:.3947.Diameter:.1850 ±.0005 specification as found:.1847.Comments: implant meets all specifications.Package received contained implant does not contain cover screw.The complaint can not be confirmed.Date of inspection: 03/20/2018.

Event Description

Complaint (b)(4) reports that packed cover screw is for 5.7mm platform, not a 4.5mm.Dentist stated "placing a 4.7x10 legacy2 implant.Noticed that the cover screw was too large for the implant.Opened another 4.7mm implant ot use that cover screw which was also too large." no patient impact.

• Brand Name: LEGACY2 4.7DX10L 4.5MMD PLATFORM
• Type of Device: DENTAL IMPLANT
• 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: crystal barczi ; 3050 e hillcrest drive; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 7351468
• MDR Text Key: 103175920
• Report Number: 3001617766-2018-00048
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307101376
• UDI-Public: 10841307101376
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 04/06/2018

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: 11/30/2022
• Device Model Number: 824710
• Device Catalogue Number: 824710
• Device Lot Number: 104853
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2018
• Initial Date FDA Received: 03/19/2018
• Supplement Dates Manufacturer Received: 02/26/2018
• Supplement Dates FDA Received: 04/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2017
• 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