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 2019-03-13 for MIS TI CFX FEN POLY 7X65 186727765 manufactured by Medos International Sàrl Ch.
[142503754]
(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
[142503755]
It was reported that - the head of the screw was disassembled when the alignment guide was introduced with a hammer for inserting the lock cap in a viper cortical fix fenestrated screw. The square thread of 2 verse correction keys were broken when they were inserted in the head of the screw. Was surgery delayed due to the reported event? --> no, action taken when event occurred? --> to change the screw and the correction keys, was procedure successfully completed? --> yes, were fragments generated? --> yes, if yes, were they removed easily without additional intervention? --> yes, patient status/ outcome / consequences --> no, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc. )? --> no, was other medical intervention (e. G. X-rays, additional procedures, prescriptions, otc, revision) required: --> no, is the patient part of a clinical study --> no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2019-51446 |
| MDR Report Key | 8416828 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-13 |
| Date of Report | 2019-02-22 |
| Date of Event | 2019-02-21 |
| Date Mfgr Received | 2019-05-22 |
| Device Manufacturer Date | 2013-11-11 |
| Date Added to Maude | 2019-03-13 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| 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 7X65 |
| Generic Name | BONE CEMENT, POSTERIOR SCREW AUGMENTATION |
| Product Code | PML |
| Date Received | 2019-03-13 |
| Model Number | 186727765 |
| Catalog Number | 186727765 |
| Lot Number | APNDJ4 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-03-13 |