MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-05-15 for DIRECTOSS DXCA251025 manufactured by Implant Direct Sybron Manufacturing Llc.
[145233560]
Per complaint (b)(4), it was reported that bone graft product was mislabeled. The lot number on the label on the box was missing a digit at the end.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001617766-2019-00225 |
| MDR Report Key | 8613598 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-05-15 |
| Date of Report | 2019-05-15 |
| Date of Event | 2019-02-21 |
| Date Mfgr Received | 2019-04-15 |
| Device Manufacturer Date | 2019-01-25 |
| Date Added to Maude | 2019-05-15 |
| 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 | MS. MONICA ROCHE |
| Manufacturer Street | 3050 EAST HILLCREST DRIVE |
| Manufacturer City | THOUSAND OAKS CA 91362 |
| Manufacturer Country | US |
| Manufacturer Postal | 91362 |
| Manufacturer Phone | 8184443300 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIRECTOSS |
| Generic Name | BONE GRAFTING MATERIAL |
| Product Code | NPM |
| Date Received | 2019-05-15 |
| Catalog Number | DXCA251025 |
| Lot Number | IO1809111 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMPLANT DIRECT SYBRON MANUFACTURING LLC |
| Manufacturer Address | 3050 EAST HILLCREST DRIVE THOUSAND OAKS CA 91362 US 91362 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-15 |