MAUDE Adverse Event Report: NOBEL BIOCARE AB BRANEMARK SYSTEM ZYGOMA TIUNITE 50MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	34739
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/02/2019
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: BRANEMARK SYSTEM ZYGOMA TIUNITE 50MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovgen 2; karlskoga, SE-69 151; SW SE-69151
• MDR Report Key: 9259196
• Report Number: 9611993-2019-21663
• Device Sequence Number: 11365028
• Product Code: DZE
• UDI-Device Identifier: 07332747013511
• UDI-Public: (01)07332747013511(10)12096551(17)220928
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K050641
• 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): 10/04/2019

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: 09/28/2022
• Device Model Number: 34739
• Device Catalogue Number: 34739
• Device Lot Number: 12096551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 10/31/2019
• 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: 48 YR