MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-10-01 for MIS TI CFX FEN POLY 7X45 186727745 manufactured by Medos International Sàrl Ch.
[122310675]
(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
[122310676]
It was reported an l3-s1 mis tlif + posterior instrumented fusion: (b)(6); (b)(6) hospital (b)(6) 2018. Whilst trying to seat the rod, surgeon was unable to reduce set screw into head of tulip. Tried multiple times. Surgeon requested x-ray. On x-ray it was apparent that the tulip had disengaged from shank of screw. Surgeon was able to release tulip from extension tube. Shank of screw was backed out by t20 driver in expedium kit. This took 2 hours, additional time for patient under anaesthesia. Surgeon would like device report as to this lot number to minimise risk to other patients. Not a desirable outcome for his patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2018-50928 |
| MDR Report Key | 7922423 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-10-01 |
| Date of Report | 2018-09-03 |
| Date of Event | 2018-09-04 |
| Date Mfgr Received | 2018-10-16 |
| Device Manufacturer Date | 2014-07-23 |
| Date Added to Maude | 2018-10-01 |
| 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 | JASON BUSCH |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088808100 |
| 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 | 2018-10-01 |
| Returned To Mfg | 2018-10-11 |
| Model Number | 186727745 |
| Catalog Number | 186727745 |
| Lot Number | ARJDKD |
| 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 | 2018-10-01 |