MAUDE Adverse Event Report: NOBEL BIOCARE USA, LLC TEMPORARY ABUTMENT NON-ENGAGING CC RP; ENDOSSEOUS DENTAL IMPLANT ABUTMENT

Model Number	36662
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Remedial action will be performed through capa #(b)(4) / pfa (b)(4).
Event or Problem Description
Nobel biocare received this complaint on may 23, 2019 from a customer in (b)(6) stating that an incorrect screw was packed with article 36662 (temporary abutment non-engaging cc rp), lot 13078005.The incorrect screws were not used on a patient.Inspection of the retain and complaint samples confirmed that the blisters contained halb 20034 (catalog number 37893) instead of the intended screw halb 12320 (catalog number 37892).Manufacturer investigation: investigation showed that article 36662 was assembled with halb 12320 screws from batch 12122536.Immediate actions taken, e.G.Quality hold/batch restriction incl.Date: article 36662, lot 13078005 was restricted on june 11, 2019.Following the preliminary investigation, lots 13077622, 13077550, 13076822, 13077560 and 13077700 were restricted on june 27, 2019 and lot 13077551 was restricted on july 10, 2019.Root cause the root cause will be further investigated in the capa that was initiated (capa #(b)(4)).

• Brand Name: TEMPORARY ABUTMENT NON-ENGAGING CC RP
• 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: 8928656
• Report Number: 2027971-2019-00022
• Device Sequence Number: 2129057
• Product Code: NHA
• UDI-Device Identifier: 07332747034301
• UDI-Public: (01)07332747034301(10)13078005
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K974150
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/23/2019

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: 36662
• Device Catalogue Number: 36662
• Device Lot Number: 13078005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 08/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1