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

Catalog Number	37892
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/23/2019
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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
• Common Device Name: 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
• Report Number: 2027971-2019-00021
• Device Sequence Number: 2780148
• Product Code: NHA
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2019
• Report Date (Section F): 07/05/2019

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