MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-05-21 for MIS TI CFX FEN POLY 7X45 186727745 manufactured by Medos International Sàrl Ch.
[145642537]
Product complaint (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
[145642538]
It was reported that the screw fractured just below the tulip at the right sided s1 screw. Important to keep in mind the patient had a sacralized l5. The surgeons assistant was trying to reengage the viper cannulated driver, along with the t20, and the viper 3d threaded driver so that they could advance the screw. The t20 & viper 3d thgd driver both stripped in the process, followed by the screw breaking just below the tulip. The surgeon was able to use universal removal to take the broken piece out. Note that we continued to have a problem with extensions at that same spot, they kept disengaging. There was nothing wrong with the extensions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2019-51679 |
| MDR Report Key | 8627838 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-05-21 |
| Date of Report | 2019-05-02 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2019-06-26 |
| Device Manufacturer Date | 2019-01-24 |
| Date Added to Maude | 2019-05-21 |
| 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 7X45 |
| Generic Name | BONE CEMENT, POSTERIOR SCREW AUGMENTATION |
| Product Code | PML |
| Date Received | 2019-05-21 |
| Returned To Mfg | 2019-05-15 |
| Model Number | 186727745 |
| Catalog Number | 186727745 |
| Lot Number | 230547 |
| 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 | 2019-05-21 |