MAUDE Adverse Event Report: INSTITUT STRAUMANN AG BLX IMMEDIATE PLACEMENT IMPLANT; IMPLANT, ENDOSSEOUS, ROOT-FORM

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Failure of Implant (1924); Inflammation (1932); Nerve Damage (1979); Pain (1994); Swelling/ Edema (4577)

Event Date 05/31/2022

Event Type  Injury  

Event Description

Reporter calling after experiencing pain and other problems after placement of a blx dental implant.Reporter states that her during the implant appointment, the dentist was "twisting my neck" and "pushing my shoulder" to extract an infected tooth which later resulted in a pinched nerve in her neck and numerous weeks of physical therapy.A blx immediate placement implant was placed at the site and "tissue from my cheek" was placed over the site for initial healing until an abutment could be placed at a later time.On approximately (b)(6) 2022, reporter started experiencing pain but was informed that the implant site was healing and that she should not worry.She continued experiencing pain, with gum inflammation and swelling when abutment was placed on (b)(6) 2022.At that time, reporter states she was informed that the abutment is placed close to the ligament of the tooth next to it.On (b)(6) 2022, the abutment was removed but the implant site was not healed enough at that time for tooth placement.Reporter states her dentist told her that there is "no gum tissue" and that it "looks like a drywall screw." reporter states her dentist told her the implant screw "looks too big" and "should not have been used." reporter states she researched information about the blx system and discovered that it is "contraindicated for diabetics".Reporter also states that prior to implant placement, no new x-rays were performed and "they used old x-rays" of her mouth.Reporter contacted the device manufacturer about her problems and has concerns that her dentist was improperly trained regarding the use of the blx system.She states that the device was improperly used on her and this process has been very frustrating.Reporter states she will need to have future dental surgeries and procedures as a result.

• Brand Name: BLX IMMEDIATE PLACEMENT IMPLANT
• Type of Device: IMPLANT, ENDOSSEOUS, ROOT-FORM
• Manufacturer (Section D): INSTITUT STRAUMANN AG
• MDR Report Key: 16939647
• MDR Text Key: 315414802
• Report Number: MW5117544
• 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: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Treatment: BLX HEALING ABUTMENT.
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Sex: Female