MAUDE Adverse Event Report: NOBEL BIOCARE AB REPLACE SELECT TC NP 3.5X(7+3)MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	36285
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
Implant failed due to a loss of osseointegration.

• Brand Name: REPLACE SELECT TC NP 3.5X(7+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: 9839627
• Report Number: 9611993-2020-13568
• Device Sequence Number: 11484668
• Product Code: DZE
• UDI-Device Identifier: 07332747022742
• UDI-Public: (01)07332747022742(10)12070029(17)210715
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K050258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 02/20/2020

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: 07/15/2021
• Device Model Number: 36285
• Device Catalogue Number: 36285
• Device Lot Number: 12070029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/17/2020
• 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: 64 YR