MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-03 for X-STOP 14MM manufactured by Kyphon Sarl.
[129461061]
I was on caudal epidural injections for 4 years prior to this event, it came to light that i had an anterior slip. It was recommended in 2006 that i had a full fixation of my l5/l4 /l3. The hospital was taken over by a trust they stopped this procedure cost cutting, i was then in all there wisdom fitted with an x stop device on (b)(6) 2007. (b)(4), size 14 mm, lot: 070214. After 4 months, it broke apart causing me to be bedridden and had several painkilling injections. As an emergency, it was taken out. I was put on morphine which i am still on today. Please could you give me any information as to this part number and also what type or period of training a surgeon would have to undergo to fit the xstop device. Any device would be greatly appreciated. Regards, (b)(6). Dates of use: (b)(6) 2007- (b)(6) 2007. Diagnosis or reason for use: spinal fusion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081805 |
| MDR Report Key | 8129038 |
| Date Received | 2018-12-03 |
| Date of Report | 2018-11-30 |
| Date of Event | 2007-07-03 |
| Date Added to Maude | 2018-12-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | X-STOP 14MM |
| Generic Name | PROSTHESIS, SPINOUS PROCESS SPACER/PLATE |
| Product Code | NQO |
| Date Received | 2018-12-03 |
| Lot Number | 070214 |
| Device Expiration Date | 2007-07-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KYPHON SARL |
| Manufacturer Address | 1800 PYRAMID PLACE MEMPHIS TN 38132 US 38132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention; 4. Deathisabilit | 2018-12-03 |