MAUDE Adverse Event Report: NOBELZYGOMA 0° 47.5MM; ENDOSSEOUS DENTAL IMPLANT

NOBELZYGOMA 0° 47.5MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	38281
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed due to a failure to osseointegrate.

Search Alerts/Recalls

1 Device was Involved in the Event
Brand Name	NOBELZYGOMA 0° 47.5MM
Common Device Name	ENDOSSEOUS DENTAL IMPLANT
MDR Report Key	12732425
Report Number	2027971-2021-125184
Device Sequence Number	1466926
Product Code	DZE
UDI-Device Identifier	07332747161526
UDI-Public	(01)07332747161526(10)12163102(17)251002
Combination Product (Y/N)	N
Initial Reporter Country	SZ
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	Importer
Initial Reporter Occupation	Dentist
Type of Report	Initial
Report Date (Section F)	11/01/2021
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	10/02/2025
Device Model Number	38281
Device Catalogue Number	38281
Device Lot Number	12163102
Was Device Available for Evaluation?	Device Returned to Manufacturer
Date Returned to Manufacturer	10/22/2021
Was the Report Sent to FDA?	No
Distributor Facility Aware Date	10/22/2021
Event Location	Outpatient Treatment Facility
Initial Date Received by Manufacturer	Not provided
Initial Report FDA Received Date	11/01/2021
Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N)	No
Usage of Device	N
Patient Sequence Number	1
Outcome Attributed to Adverse Event	Required Intervention;
Patient Age	52 YR
Date Report Sent to FDA	11/01/2021