MAUDE Adverse Event Report: STERNGOLD DENTAL LLC MOR; IMPLANT

Device Problem Break (1069)

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

Event Date 06/06/2019

Event Type  malfunction  

Event Description

Implant broke off during insertion of implant into patient and is lodged in teh implant latch driver.Drilled with 2.0 drill, then insertion tool, to wing driver and then latch driver with a graduated type of torque wrenchfor the last few turns to 35ncm.

• Brand Name: MOR
• Type of Device: IMPLANT
• Manufacturer (Section D): STERNGOLD DENTAL LLC; 23 frank mossberg dr; attleboro MA 02703
• Manufacturer Contact: 23 frank mossberg dr; attleboro, MA 02703 ; 5082265660
• MDR Report Key: 9075379
• MDR Text Key: 191832294
• Report Number: 2921595-2019-00007
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/13/2019

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?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 64 YR