MAUDE Adverse Event Report: NOBEL BIOCARE USA, LLC REPLACE SELECT TAPERED TIU 6.0 6.0X8MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	36110
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: (b)(4).Revoked asr exemption number e1997036 'report late due to asr to individual reporting transition.'.
Event or Problem Description
Implant failed dur to loss of osseointegration.

• Brand Name: REPLACE SELECT TAPERED TIU 6.0 6.0X8MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE USA, LLC; 22715 savi ranch parkway; yorba linda CA 92887 7149
• MDR Report Key: 9056074
• Report Number: 2027971-2019-17411
• Device Sequence Number: 2192451
• Product Code: DZE
• UDI-Device Identifier: 07332747022629
• UDI-Public: (01)07332747022629(10)494734(17)181021
• Combination Product (Y/N): N
• Initial Reporter Country: AF
• PMA/510(K) Number: K023113
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 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 Expiration Date: 10/21/2018
• Device Model Number: 36110
• Device Catalogue Number: 36110
• Device Lot Number: 494734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2019
• Initial Report FDA Received Date: 09/14/2019
• 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: 61 YR