MAUDE Adverse Event Report: NOBEL BIOCARE USA, LLC NOBELREPLACE TAPERED GROOVY 6.0 6X16MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	32226
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
Implant failed due to a failure to osseointegrate.

• Brand Name: NOBELREPLACE TAPERED GROOVY 6.0 6X16MM
• 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: 9691771
• Report Number: 2027971-2020-02421
• Device Sequence Number: 1942345
• Product Code: DZE
• UDI-Device Identifier: 07332747001945
• UDI-Public: (01)07332747001945(10)13023286(17)200918
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K050258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/14/2020

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: 09/18/2020
• Device Model Number: 32226
• Device Catalogue Number: 32226
• Device Lot Number: 13023286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 02/11/2020
• 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: 84 YR