MAUDE Adverse Event Report: STRAUMANN MANUFACTURING, INC. DENTAL IMPLANT; IMPLANT, ENDOSSEOUS, ROOT-FORM

Lot Number AFV08

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)

Event Date 12/27/2022

Event Type  malfunction  

Event Description

I had an implant placed in tooth #5 on (b)(6) 2021.The manufacturer is straumann, platform diameter 4.5mm, length is 8mm, and style is blx/rb.In (b)(6) of 2022, my abutment screw broke and now it is stuck and irretrievable from my implant, although many attempts were made on (b)(6) 2023 by expert periodontists.This now ultimately makes my implant unusable.I have been recommended to extract the implant and redo the implant procedure as well as the post abutment and crown process.

• Brand Name: DENTAL IMPLANT
• Type of Device: IMPLANT, ENDOSSEOUS, ROOT-FORM
• Manufacturer (Section D): STRAUMANN MANUFACTURING, INC.
• MDR Report Key: 16279040
• MDR Text Key: 308652857
• Report Number: MW5114619
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/30/2023

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 Lot Number: AFV08
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2023
• Patient Sequence Number: 1
• Treatment: FISH OIL; VITAMIN B COMPLEX; VITAMIN D; WOMEN'S ONE A DAY
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian