MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-14 for SIMPLYLEGACY DRIVER HT3.0LG manufactured by Implant Direct Sybron Manufacturing Llc.
[179412014]
Per complaint (b)(4), during clinical procedure, 3. 0 driver welded into the platform of implant. Implant was removed and driver was still stuck.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001617766-2020-01602 |
| MDR Report Key | 9710746 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-14 |
| Date of Report | 2020-02-14 |
| Date of Event | 2019-10-16 |
| Date Mfgr Received | 2019-11-11 |
| Device Manufacturer Date | 2017-03-09 |
| Date Added to Maude | 2020-02-14 |
| 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 |
| Reporter Occupation | DENTIST |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 4443300357 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIMPLYLEGACY DRIVER |
| Generic Name | DENTAL IMPLANT |
| Product Code | NDP |
| Date Received | 2020-02-14 |
| Returned To Mfg | 2019-12-17 |
| Model Number | HT3.0LG |
| Catalog Number | HT3.0LG |
| Lot Number | 90792 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-14 |