MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-10 for SYSTEM 26 K-WIRE FOR 4.0MM SCREW DRILL TIP THREADED TIP 1.6X150MM OS900030-S manufactured by Ortho Solutions Uk Limited.
| Report Number | 3008951116-2020-00003 |
| MDR Report Key | 9812646 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-05 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2019-07-10 |
| Date Added to Maude | 2020-03-10 |
| 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 LIMITED |
| Manufacturer Street | WEST STATION BUSINESS PARK SPITAL ROAD |
| Manufacturer City | MALDON, ESSEX, CM9 6FF |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CM9 6FF |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYSTEM 26 K-WIRE FOR 4.0MM SCREW DRILL TIP THREADED TIP 1.6X150MM |
| Generic Name | ORTHOPAEDIC BONE WIRE |
| Product Code | HTY |
| Date Received | 2020-03-10 |
| Model Number | OS900030-S |
| Catalog Number | OS900030-S |
| Lot Number | 1A2478 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHO SOLUTIONS UK LIMITED |
| Manufacturer Address | WEST STATION BUSINESS PARK SPITAL ROAD MALDON, ESSEX, CM9 6FF UK CM9 6FF |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-10 |