MAUDE Adverse Event Report: NOBELZYGOMA 45° 40MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	38287
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed due to a failure to osseointegrate.

• Brand Name: NOBELZYGOMA 45° 40MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• MDR Report Key: 12748593
• Report Number: 9611993-2021-103519
• Device Sequence Number: 4852136
• Product Code: DZE
• UDI-Device Identifier: 07332747102772
• UDI-Public: (01)07332747102772(10)12109745(17)230401
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152093
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial

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: 04/01/2023
• Device Model Number: 38287
• Device Catalogue Number: 38287
• Device Lot Number: 12109745
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR