MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-08-20 for MIS TI CFX FEN POLY 6X50 186727650 manufactured by Medos International Sàrl Ch.
Report Number | 1526439-2019-52008 |
MDR Report Key | 8910555 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2019-08-20 |
Date of Report | 2019-07-23 |
Date Mfgr Received | 2019-10-10 |
Device Manufacturer Date | 2014-12-05 |
Date Added to Maude | 2019-08-20 |
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 | KARA DITTY-BOVARD |
Manufacturer Street | 325 PARAMOUNT DRIVE |
Manufacturer City | RAYNHAM MA 02400 |
Manufacturer Country | SZ |
Manufacturer Postal | 02400 |
Manufacturer Phone | 6103142063 |
Manufacturer G1 | MEDOS INT SPINE |
Manufacturer Street | CHEMIN BLANC 38 |
Manufacturer City | LE LOCLE |
Manufacturer Country | SZ |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | MIS TI CFX FEN POLY 6X50 |
Generic Name | BONE CEMENT, POSTERIOR SCREW AUGMENTATION |
Product Code | PML |
Date Received | 2019-08-20 |
Returned To Mfg | 2019-08-22 |
Model Number | 186727650 |
Catalog Number | 186727650 |
Lot Number | ARPBMJ |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MEDOS INTERNATIONAL SàRL CH |
Manufacturer Address | CHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2019-08-20 |