MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-23 for RETRIEVAL SCREW manufactured by Neobiotech Co. Ltd..
[114745319]
It was reported that unknown retrieval screw fractured inside of the dental implant.. Implant had to be trephined out. No implant was placed and patient was sent home to heal. Tooth location # 31. Bone density type iii.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001038806-2018-00690 |
| MDR Report Key | 7711418 |
| Date Received | 2018-07-23 |
| Date of Report | 2018-07-23 |
| Date Facility Aware | 2018-06-01 |
| Report Date | 2018-07-20 |
| Date Reported to Mfgr | 2018-07-20 |
| Date Added to Maude | 2018-07-23 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | RETRIEVAL SCREW |
| Product Code | DZA |
| Date Received | 2018-07-23 |
| Returned To Mfg | 2018-07-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEOBIOTECH CO. LTD. |
| Manufacturer Address | E-SPACE #105 212-26 GURO-DONG, SEOUL 152-789 KS 152-789 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-07-23 |