MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-02-08 for LOCATOR DRILL LDRILL manufactured by Implant Direct Sybron Manufacturing Llc.
[135724141]
Per complaint (b)(4), a vial for a step drill was packaged with a cortical bone drill.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001617766-2019-00050 |
| MDR Report Key | 8324306 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-02-08 |
| Date of Report | 2019-03-20 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2019-03-12 |
| Device Manufacturer Date | 2018-11-05 |
| Date Added to Maude | 2019-02-08 |
| 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 | MRS. ADRIENNE STOTT |
| 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 | LOCATOR DRILL |
| Generic Name | LOCATOR DRILL |
| Product Code | DZI |
| Date Received | 2019-02-08 |
| Returned To Mfg | 2019-02-08 |
| Catalog Number | LDRILL |
| Lot Number | 127062 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-02-08 |