MAUDE Adverse Event Report: NOBEL BIOCARE AB REPLACE SELECT TC NP 3.5X(15+3)MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	36288
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Revoked asr exemption number e1997036.'"report late due to asr to individual reporting transition"'.Nobel biocare is both the manufacturer and importer and no report from the importer to the manufacturer is needed.
Event or Problem Description
Implant failed due to loss of osseointegration.

• Brand Name: REPLACE SELECT TC NP 3.5X(15+3)MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovgen 2; karlskoga, SE-69 151; SW SE-69151
• MDR Report Key: 9020801
• Report Number: 2027971-2019-08892
• Device Sequence Number: 11235680
• Product Code: DZE
• UDI-Device Identifier: 07332747022735
• UDI-Public: (01)07332747022735(10)12032639(17)191106
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 07/17/2019
• Report Date (Section F): 09/13/2019

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: 11/06/2019
• Device Model Number: 36288
• Device Catalogue Number: 36288
• Device Lot Number: 12032639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/17/2019
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2019
• 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: 47 YR
• Date Report Sent to FDA: 09/13/2019