MAUDE Adverse Event Report: BIOHORIZON IMPLANT SYSTEMS, INC. TAPERED INTERNAL IMPLANT; IMPLANT, ENDOSSEOUS, ROOT-FORM

Device Problem Break (1069)

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

Event Date 03/01/2018

Event Type  malfunction  

Event Description

I received a dental implant on (b)(6) 2015.The screw that is anchored in my gum broke on 4 occasions since then and my tooth fell off.The screws broke and i returned to the dentist for repair on (b)(6) 2018, (b)(6) 2018, (b)(6) 2019 and (b)(6) 2020.Each time i returned when the tooth broke off, the screw had broken.The dentist had to get the broken screw out of my gum.When i returned each time when the tooth came off, i had to get my gum lasered since the gum grew over the implant screw.This caused a lot of pain afterwards.I also had to pay for services not covered by my insurance each time.The dentist said that the reason why it broke so many times was because i was grinding my teeth.The company told him to adjust my bite by shaving off some of my tooth but this didn't help.The implant came from a company called (b)(4).It¿s a tapered internal implant tlr4612.The lot ref # is (b)(4).Fda safety report id # (b)(4).

• Brand Name: TAPERED INTERNAL IMPLANT
• Type of Device: IMPLANT, ENDOSSEOUS, ROOT-FORM
• Manufacturer (Section D): BIOHORIZON IMPLANT SYSTEMS, INC.
• MDR Report Key: 11131767
• MDR Text Key: 225812812
• Report Number: MW5098718
• Device Sequence Number: 3
• Product Code: DZE
• 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: 01/05/2021
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/06/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 73