MAUDE Adverse Event Report: STERNGOLD DENTAL LLC MOR; IMPLANT

Model Number 901484

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/28/2019

Event Type  malfunction  

Event Description

Implant ball head broke off when torquing into dense bone.One of the ball heads also got stuck inside of his wing driver.

• Brand Name: MOR
• Type of Device: IMPLANT
• Manufacturer (Section D): STERNGOLD DENTAL LLC; 23 frank mossberg drive; attleboro MA 02703
• Manufacturer Contact: diane tiernan ; 23 frank mossberg drive; attleboro, MA 02703 ; 5082265660
• MDR Report Key: 9075373
• MDR Text Key: 191831856
• Report Number: 2921595-2019-00005
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• 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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2021
• Device Model Number: 901484
• Device Lot Number: X650116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 09/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2016
• 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: 52 YR