MAUDE Adverse Event Report: NOBEL BIOCARE AB BRANEMARK SYSTEM ZYGOMA TIUNITE 52.5MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	34740
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Pain (1994)
Date of Event	11/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: (b)(4).Revoked asr exemption number e1997036 report late due to asr to individual reporting transition.
Event or Problem Description
Implant failed due to loss of osseointegration.

• Brand Name: BRANEMARK SYSTEM ZYGOMA TIUNITE 52.5MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovgen 2; karlskoga, SE-69 151; SW SE-69151
• MDR Report Key: 8989050
• Report Number: 9611993-2019-01607
• Device Sequence Number: 3380891
• Product Code: DZE
• UDI-Device Identifier: 07332747013528
• UDI-Public: (01)07332747013528(10)12046834(17)200716
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K050641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 05/28/2019

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: 07/16/2020
• Device Model Number: 34740
• Device Catalogue Number: 34740
• Device Lot Number: 12046834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 09/11/2019
• 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: 68 YR