| Brand Name | ABUT TAPERED 1-PC SCREW-VENT 3.5MM 1MM |
|---|
| Type of Device | DENTAL ABUTMENT |
|---|
| Manufacturer (Section D) |
| ZIMMER DENTAL |
| 4555 riverside drive |
| palm beach gardens FL 33410 |
|
|---|
| Manufacturer (Section G) |
| ZIMMER DENTAL |
| 4555 riverside drive |
|
| palm beach gardens FL 33410 |
|
|---|
| Manufacturer Contact |
|
susanne
taylor
|
| 4555 riverside drive |
| palm beach gardens, FL 33410
|
|
5619713230
|
|
|---|
| MDR Report Key | 18501997 |
|---|
| MDR Text Key | 332764208 |
|---|
| Report Number | 0002023141-2024-00063 |
|---|
| Device Sequence Number | 1 |
|---|
| Product Code |
NHA
|
| Combination Product (y/n) | N |
|---|
| Reporter Country Code | SP |
|---|
| PMA/PMN Number | K060880 |
|---|
| Exemption Number | 5645646 |
|---|
| Number of Events Reported | 1 |
|---|
| Summary Report (Y/N) | N |
|---|
| Report Source |
Manufacturer
|
|---|
| Source Type |
Foreign,Health Professional |
|---|
| Reporter Occupation |
Dentist
|
|---|
| Type of Report
| Initial |
|---|
| Report Date |
01/11/2024 |
|---|
| 1 Device was Involved in the Event |
|
| 1 Patient was Involved in the Event |
|
| Date FDA Received | 01/12/2024 |
|---|
| Is this an Adverse Event Report? |
Yes
|
|---|
| Is this a Product Problem Report? |
No
|
|---|
| Device Operator |
Health Professional
|
|---|
| Device Catalogue Number | TAC1 |
|---|
| Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
|---|
| Date Returned to Manufacturer | 12/28/2023 |
|---|
| Is the Reporter a Health Professional? |
Yes
|
|---|
| Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
|---|
| Is the Device Single Use? |
No
|
|---|
| Is This a Reprocessed and Reused Single-Use Device? |
No
|
|---|
| Type of Device Usage |
Unknown
|
|---|
| Patient Sequence Number | 1 |
|---|
| Patient Sex | Prefer Not To Disclose |
|---|
| Patient Ethnicity | Non Hispanic |
|---|
