MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-26 for DRILL BIT 2.0MM X 123MM CALIBRATED OS200020LC manufactured by Ortho Solutions Uk Ltd.
| Report Number | 3008951116-2020-00005 |
| MDR Report Key | 9883035 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2017-03-07 |
| Date Added to Maude | 2020-03-26 |
| 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 SAMUEL CHONG |
| Manufacturer Street | UNIT 5, WEST STATION BUSINESS SPITAL ROAD |
| Manufacturer City | MALDON, ESSEX CM9 6FF |
| Manufacturer Country | UK |
| Manufacturer Postal | CM9 6FF |
| Manufacturer G1 | ORTHO SOLUTIONS UK LTD |
| Manufacturer Street | UNIT 5, WEST STATION BUSINESS SPITAL ROAD |
| Manufacturer City | MALDON, ESSEX CM9 6FF |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CM9 6FF |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRILL BIT 2.0MM X 123MM CALIBRATED |
| Generic Name | FLUTED SURGICAL DRILL BIT, SINGLE-USE, STERILE |
| Product Code | HTW |
| Date Received | 2020-03-26 |
| Model Number | OS200020LC |
| Catalog Number | OS200020LC |
| Lot Number | 1088789 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHO SOLUTIONS UK LTD |
| Manufacturer Address | UNIT 5, WEST STATION BUSINESS SPITAL ROAD MALDON, ESSEX CM9 6FF UK CM9 6FF |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-26 |