MAUDE Adverse Event Report: NOBEL BIOCARE AB NOBELSPEEDY GROOVY RP 4.0X22MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	37612
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
Implant failed because primary stability could not be achieved.

• Brand Name: NOBELSPEEDY GROOVY RP 4.0X22MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovgen 2; karlskoga, SE-69 151; SW SE-69151
• MDR Report Key: 9620528
• Report Number: 9611993-2020-04158
• Device Sequence Number: 18958456
• Product Code: DZE
• UDI-Device Identifier: 07332747086256
• UDI-Public: (01)07332747086256(10)12045844(17)200605
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K160119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 12/27/2019

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: 06/05/2020
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Device Lot Number: 12045844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 01/23/2020
• 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: 66 YR