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

Model Number 36662

Device Problem Component Misassembled (4004)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Remedial action will be performed through capa #(b)(4) / pfa (b)(4).

Event 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
• Type of Device: ENDOSSEOUS DENTAL IMPLANT ABUTMENT
• Manufacturer (Section D): NOBEL BIOCARE USA, LLC; 22715 savi ranch parkway; yorba linda CA 92887 7149
• Manufacturer (Section G): NOBEL BIOCARE USA, LLC; 22715 savi ranch parkway; yorba linda CA 92887 7149
• Manufacturer Contact: willem van alst ; kozakkenberg 4; belfeld, 5951D-L ; NL 5951DL
• MDR Report Key: 8928658
• MDR Text Key: 178739501
• Report Number: 2027971-2019-00023
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 07332747034301
• UDI-Public: (01)07332747034301(10)13078005
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K974150
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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: 06/03/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1