MAUDE Adverse Event Report: NOBEL BIOCARE AB NOBELSPEEDY GROOVY WP 6X8.5MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	32140
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/16/2019
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: NOBELSPEEDY GROOVY WP 6X8.5MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovgen 2; karlskoga, SE-69 151; SW SE-69151
• MDR Report Key: 9737212
• Report Number: 9611993-2020-08157
• Device Sequence Number: 1973890
• Product Code: DZE
• UDI-Device Identifier: 07332747001389
• UDI-Public: (01)07332747001389(10)12004900(17)180825
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/23/2020

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: 08/25/2018
• Device Model Number: 32140
• Device Catalogue Number: 32140
• Device Lot Number: 12004900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 02/21/2020
• 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: 68 YR