MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY IMPLANT OPEN-TRAY TRANSFER; IMPRESSION COPING

Catalog Number 8045-08

Device Problem Separation Failure (2547)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 06/06/2019

Event Type  Injury  

Event Description

Per complaint (b)(4), an impression coping would not unscrew from a dental implant while crown impressions were being taken.The implant was backed out.The patient experienced pain.

Manufacturer Narrative

Follow-up submitted to report device evaluation.

• Brand Name: LEGACY IMPLANT OPEN-TRAY TRANSFER
• Type of Device: IMPRESSION COPING
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 8786970
• MDR Text Key: 150901410
• Report Number: 3001617766-2019-00303
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307121534
• UDI-Public: 10841307121534
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8045-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 07/12/2019
• Supplement Dates Manufacturer Received: 07/15/2019
• Supplement Dates FDA Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR