MAUDE Adverse Event Report: NOBEL BIOCARE AB CLINICAL SCREW CC NP; ENDOSSEOUS DENTAL IMPLANT ABUTMENT

Catalog Number 37892

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Failure of Implant (1924)

Event Date 04/23/2019

Event Type  Injury  

Event Description

A patient called to place a complaint that she tasted metal after implant treatment.She expressed concerns that our implants had hugely impacted her immune system.Melisa test documentation, performed on may 17, 2019, was provided which indicated a strongly positive stimulation index reaction to nickel (9.7) and a positive reaction to manganese i (4).Additional chemotechnique diagnostic results indicated that the patient also has a contact allergy to vanadium.Internal investigation into the implant components confirmed that the allergenics (nickel, vanadium and manganese) are not found in the implanted products.It was however confirmed that certain clinical abutment screws from nobel biocare contain vanadium, which could have contributed to the patient's complaint.

Manufacturer Narrative

(b)(4).

Event Description

A patient called to place a complaint that she tasted metal after implant treatment.She expressed concerns that our implants had hugely impacted her immune system.(b)(6) test documentation, performed on (b)(6) 2019, was provided which indicated a strongly positive stimulation index reaction to nickel (9.7) and a positive reaction to manganese i (4).Additional chemotechnique diagnostic results indicated that the patient also has a contact allergy to vanadium.Internal investigation into the implant components confirmed that the allergenics (nickel, vanadium and manganese) are not found in the implanted products.It was however confirmed that certain clinical abutment screws from nobel biocare contain vanadium, which could have contributed to the patient's complaint.

• Brand Name: CLINICAL SCREW CC NP
• Type of Device: ENDOSSEOUS DENTAL IMPLANT ABUTMENT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovgen 2; karlskoga, SE-69 1 5; SW SE-69 1 51
• MDR Report Key: 8764146
• MDR Text Key: 150129038
• Report Number: 2027971-2019-00021
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: LH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 07/05/2019,06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 37892
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/05/2019
• Distributor Facility Aware Date: 05/28/2019
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/28/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR