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 2019-04-26 for MIS TI CFX FEN POLY 7X45 186727745 manufactured by Medos International Sàrl Ch.
[145251540]
(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
[145251541]
The following was reported: screw breakage. It was reported that during the posterior lumbar closed reposition and internal fixation + vertebral augmentation, when did subcutaneous rod insertion, the screw extender along with the screw head fell off, used the screw removal tool to retrieve the screw rod, it was noted that the connecting ring between the screw head and the screw rod was broken off as the photo shows. The surgery delayed about 30 minutes. The patient is stable and in hospital now.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2019-51569 |
| MDR Report Key | 8556899 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-26 |
| Date of Report | 2019-04-01 |
| Date of Event | 2019-03-26 |
| Date Mfgr Received | 2019-06-17 |
| Device Manufacturer Date | 2018-07-07 |
| Date Added to Maude | 2019-04-26 |
| 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 | 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 7X45 |
| Generic Name | BONE CEMENT, POSTERIOR SCREW AUGMENTATION |
| Product Code | PML |
| Date Received | 2019-04-26 |
| Returned To Mfg | 2019-05-02 |
| Model Number | 186727745 |
| Catalog Number | 186727745 |
| Lot Number | 206837 |
| 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 | 2019-04-26 |