MAUDE Adverse Event Report: NOBEL BIOCARE USA, LLC HEALING ABUTMENT NOBRPL RP Ø5.3X5MM; ENDOSSEOUS DENTAL IMPLANT ABUTMENT.

Model Number	33452
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
On april 23, 2019 a customer in the us returned 10 products labeled 36644 (healing abutment cc rp ø3.6x5mm), lot 13076845, stating the packages contain an incorrect healing abutment.Inspection performed by nobel biocare confirmed that all ten packages contain article 33452 (healing abutment nobrpl rp ø5.3x5mm), lot 13076868.Investigation concluded that 16 pieces of article 33452, lot 13076868 had been incorrectly labeled as article 36644, lot 13076845.An extra label sheet (including 16 individual labels) had been printed for complained lot 13076845.Instead of the sheet being scrapped, it was in error used on article 33452, lot 13076868.A health hazard evaluation was performed concluding on a high risk for the patient: a misfit between the abutment and the implant could potentially lead to inflammation or damage to the implant due to increased forces on the implant threads.Both issues could result in a need for revision surgery.Corrective or removal actions that have been, and are expected to be taken: the following corrective actions were implemented: the affected lot 13076845 was restricted on may 01, 2019.A capa was initiated to further investigate the issue and to implement corrective and preventive actions.The following removal actions will be implemented: a recall will be initiated to remove all pieces labeled article 36644, lot 13076845 from the market.

• Brand Name: HEALING ABUTMENT NOBRPL RP Ø5.3X5MM
• 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: 8636034
• Report Number: 2027971-2019-00008
• Device Sequence Number: 11285581
• Product Code: NHA
• UDI-Device Identifier: 07332747002881
• UDI-Public: (01)07332747002881(10)13076868(17)211219
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K925779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/23/2019

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 Expiration Date: 12/19/2021
• Device Model Number: 33452
• Device Catalogue Number: 33452
• Device Lot Number: 13076868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1