MAUDE Adverse Event Report: NOBEL BIOCARE USA, LLC ESTHETIC ABUTMENT CC RP 1.5MM; ENDOSSEOUS DENTAL IMPLANT ABUTMENT.

Model Number	36669
Medical Device Problem Codes	Incomplete or Missing Packaging (2312); Component Misassembled (4004)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Nobel biocare was verbally informed by the customer on the (b)(6) 2019 that ordered material #(b)(4) (esthetic abutment cc rp 1.5mm) batch #13075989 contained an incorrect screw.Nobel biocare received the returned product on the august 19, 2019.No further information is available at this moment.
Additional Manufacturer Narrative
Internal reference number: (b)(4).Manufacturer narrative: the returned product was received opened but not used.The state in which the product was returned prevented verification of the material number indicated on the complaint file.The information provided by the customer was used to process this complaint.Visual inspection showed a virtually unscathed abutment and screw.The returned screw appeared to be narrower than the screw that should have been supplied with this abutment, material 37892 (clinical screw conical connection rp/wp).The screw head appeared to be straight, rather than angled inward at the top.The returned screw did not have a black coating.The size, shape, and color of the returned screw indicated that it was material 37891 (clinical screw conical connection np).The returned screw was compared with the technical drawings 34201, and 37826.The length, and diameter correspond with the technical drawing 37826, material 37891.Trend analysis indicated 1 similar complaints with the same material and batch combination, internal reference number 202336304.A device history check found no anomalies from the production process and retain samples conformed.Detectability of the wrong screw is noticeable as the screw will not tighten when placed due to the narrow platform.The customer will not accidentally place the wrong screw.Should the customer not have a replacement screw at the time of loading, the most likely outcome would be a delay in loading the abutment onto the implant which would not result in patient injury.Corrected data: additional data included in this submission include: patient identifier: none, (b)(4).
Event or Problem Description
On (b)(6) 2019 a customer informed nobel biocare that product material number 36669 (esthetic abutment cc rp 4.5mm), batch number 13075989, was packaged with an incorrect screw.The customer returned the product, which was received by the manufacturer on (b)(6), 2019.

• Brand Name: ESTHETIC ABUTMENT CC RP 1.5MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT ABUTMENT.
• Manufacturer (Section D): NOBEL BIOCARE USA, LLC; 22715 savi ranch parkway; yorba linda CA 92887 7149
• MDR Report Key: 8921446
• Report Number: 2027971-2019-00746
• Device Sequence Number: 1904107
• Product Code: NHA
• UDI-Device Identifier: 07332747032598
• UDI-Public: (01)07332747032598(10)13075989
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K071370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2019

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
• Operator of Device: Health Professional
• Device Model Number: 36669
• Device Catalogue Number: 36669
• Device Lot Number: 13075989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1