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 2018-10-10 for MIS TI CFX FEN POLY 7X50 186727750 manufactured by Medos International Sàrl Ch.
[123678898]
(b)(4). Device is available for evaluation. Investigation will be conducted. Follow up will be filed with the investigation results. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[123678899]
Mis screwdriver broke twice with 7 mm cfx screw. Patient consequence? : no. Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1526439-2018-50976 |
MDR Report Key | 7953486 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2018-10-10 |
Date of Report | 2018-09-12 |
Date of Event | 2018-09-12 |
Date Mfgr Received | 2018-11-08 |
Device Manufacturer Date | 2016-09-01 |
Date Added to Maude | 2018-10-10 |
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 | JASON BUSCH |
Manufacturer Street | 325 PARAMOUNT DRIVE |
Manufacturer City | RAYNHAM MA 02767 |
Manufacturer Country | US |
Manufacturer Postal | 02767 |
Manufacturer Phone | 5088808100 |
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 7X50 |
Generic Name | BONE CEMENT, POSTERIOR SCREW AUGMENTATION |
Product Code | PML |
Date Received | 2018-10-10 |
Returned To Mfg | 2018-09-26 |
Model Number | 186727750 |
Catalog Number | 186727750 |
Lot Number | AVKBLH |
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 | 2018-10-10 |