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 2019-05-20 for MIS TI CFX FEN POLY 7X40 186727740S2P manufactured by Medos International Sàrl Ch.
[145604846]
Product complaint : (b)(4). :pc: surgical intervention, medical device removal (b)(4). A complaint investigation will be performed. The complaint product is not available for the investigation. A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information. Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the 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
[145604847]
It was reported that on an unknown date, during spinal fusion, (b)(6) brought the patient back to the operating room for a non-union. Both rods broke at l4, where no screws were placed from the previously implanted construct (t9-ilium). The original t9-ilium construct used expedium cocr rods. When the removal occurred, (b)(6) noticed that the screws bilaterally at l5, s1 and l3 on the right. (b)(6) decide to remove those screws and replace them by upsizing each screw by 1mm in diameter. There was no surgical delay. Procedure was successfully completed. There was no patient harm/consequence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2019-51670 |
| MDR Report Key | 8625713 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-20 |
| Date of Report | 2019-04-30 |
| Date Mfgr Received | 2019-04-30 |
| Date Added to Maude | 2019-05-20 |
| 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 7X40 |
| Generic Name | BONE CEMENT, POSTERIOR SCREW AUGMENTATION |
| Product Code | PML |
| Date Received | 2019-05-20 |
| Catalog Number | 186727740S2P |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-05-20 |