| Brand Name | BRÅNEMARK SYSTEM® ZYGOMA TIUNITE 40MM |
|---|
| Common Device Name | ENDOSSEOUS DENTAL IMPLANT |
|---|
| Manufacturer (Section D) |
| NOBEL BIOCARE AB GÖTEBORG |
| bohusgatan 15 |
| göteborg 41139 |
| SW 41139 |
|
|---|
| MDR Report Key | 20690200 |
|---|
| Report Number | 2027971-2024-142445 |
|---|
| Device Sequence Number | 20964609 |
|---|
| Product Code |
DZE
|
| UDI-Device Identifier | 07332747160178 |
|---|
| UDI-Public | (01)07332747160178(10)12215648(17)271226 |
|---|
| Combination Product (Y/N) | N |
|---|
| Initial Reporter Country | SP |
|---|
| Number of Events Summarized | 1 |
|---|
| Summary Report (Y/N) | N |
|---|
| Device Implanted Year | 2024 |
|---|
| Device Explanted Year | 2024 |
|---|
| Serviced by Third Party (Y/N) | N |
|---|
| Reporter Type |
Importer
|
|---|
| Initial Reporter Occupation |
Dentist
|
|---|
| Type of Report
| Initial |
|---|
| Report Date (Section F) |
11/14/2024 |
|---|
| 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 Catalogue Number | 34735 |
|---|
| Device Lot Number | 12215648 |
|---|
| Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
|---|
| Date Returned to Manufacturer | 11/12/2024 |
|---|
| Is the Reporter a Health Professional? |
Yes
|
|---|
| Was the Report Sent to FDA? |
No
|
|---|
| Distributor Facility Aware Date | 11/07/2024 |
|---|
| Event Location |
Outpatient Treatment Facility
|
|---|
| Initial Date Received by Manufacturer | Not provided |
|---|
| Initial Report FDA Received Date | 11/14/2024 |
|---|
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N) |
No
|
|---|
| Usage of Device |
A
|
|---|
| Patient Sequence Number | 1 |
|---|
| Outcome Attributed to Adverse Event |
Required Intervention;
|
| Patient Age | 46 YR |
|---|
| Patient Sex | Female |
|---|
| Date Report Sent to FDA | 11/14/2024 |
|---|
