MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-11-15 for MIS TI CFX FEN POLY 7X45 186727745 manufactured by Medos International Sàrl Ch.
[127273930]
(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
[127273931]
It was reported: broken rod at l5 left / caused the revision (revision case took place (b)(6) 2018). Loose pedicle screw l5 right / caused the revision (revision case took place (b)(6) 2018). Broken pedicle screw s1 right / caused the revision (revision case took place (b)(6) 2018). Broken iliac screw right / caused the revision (revision case took place (b)(6) 2018). Loose pedicle screw l5 left / caused the revision (revision case took place (b)(6) 2018). Broken expedium polyaxial screwdriver / occurred during the revision surgery (b)(6) 2018. Broken power expedium / occurred during the revision surgery (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2018-51069 |
| MDR Report Key | 8074698 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-15 |
| Date of Report | 2018-10-29 |
| Date of Event | 2018-01-01 |
| Date Mfgr Received | 2018-12-27 |
| Device Manufacturer Date | 2017-03-30 |
| Date Added to Maude | 2018-11-15 |
| 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 | 2018-11-15 |
| Returned To Mfg | 2018-11-09 |
| Model Number | 186727745 |
| Catalog Number | 186727745 |
| Lot Number | 131106 |
| 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 | 2018-11-15 |