MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-03 for INTERACTIVE SMARTBASE, NARROW 6534-82N manufactured by Implant Direct Sybron Manufacturing Llc.
[181914845]
Patient information are not applicable as there was no patient involvement. Relevant tests/lab actions are in process. Relevant history is not applicable. Implant and explant dates are not applicable as there was no patient involvement.
Patient Sequence No: 1, Text Type: N, H10
[181914846]
As per complaint (b)(4), during a review of finished goods in the implant direct distribution center it was discovered that a cap label contained the wrong part number. The part number on the label was printed as 654310u. The part number on the label should have been 6534-82n.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001617766-2020-00590 |
| MDR Report Key | 9782082 |
| Report Source | OTHER |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-02-03 |
| Device Manufacturer Date | 2019-10-24 |
| Date Added to Maude | 2020-03-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MARCOS GUTIERREZ |
| Manufacturer Street | 3050 EAST HILLCREST DRIVE |
| Manufacturer City | THOUSAND OAKS, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTERACTIVE SMARTBASE, NARROW |
| Generic Name | DENTAL IMPLANT, SUPERSTRUCTURE |
| Product Code | NHA |
| Date Received | 2020-03-03 |
| Model Number | 6534-82N |
| Catalog Number | 6534-82N |
| Lot Number | 153553 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMPLANT DIRECT SYBRON MANUFACTURING LLC |
| Manufacturer Address | 3050 EAST HILLCREST DRIVE THOUSAND OAKS, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-03 |