MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-17 for CD HORIZON SPINAL SYSTEM 5484805 manufactured by Medtronic Sofamor Danek Usa, Inc.
[114677430]
Product was not returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the r eported event. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[114677431]
Pre-op diagnosis: lumbar spinal canal stenosis procedure: transforaminal lumbar interbody fusion (tlif) levels implanted: l3/4/5 it was reported that on (b)(6) 2018, intra-op, the screws were inserted without problem at first, and 4mm reduction screw was placed only for l3. There was also no problem with inserting the rod, and it was placed on l4/5 until "rd" and provisional fixation was performed, and there was no problem with the provisional fixation on the left side. The provisional fixation was performed on the right side of l4, and when l5 set screw was attempted to be inserted, the situation was that it could not be tightened until the end although it gripped in the middle. When the set screw was checked, it was confirmed that it was gouged. No matter how many times the surgeon tried with new set screws, there was no effect. It was suspected that there might be something wrong with the screw head. Therefore, the screw was removed and replaced with a new screw, and the new screw was inserted again. The rod was placed and the provisional fixation was attempted to be performed, but it could not be performed again on the right side of l5. When checking it by image, it was obvious that the extender was disengaged, so the screw was removed again. As there was a backup extender, this one was used instead, and then there was no problem with the tightening. No patient complications were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[124180381]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2018-01010 |
| MDR Report Key | 7693327 |
| Date Received | 2018-07-17 |
| Date of Report | 2018-10-03 |
| Date of Event | 2018-06-20 |
| Date Mfgr Received | 2018-08-08 |
| Device Manufacturer Date | 2010-09-30 |
| Date Added to Maude | 2018-07-17 |
| 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 | STACIE ZIEMBA |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Street | 4340 SWINEA RD |
| Manufacturer City | MEMPHIS TN 38118 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38118 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CD HORIZON SPINAL SYSTEM |
| Generic Name | GONIOMETER, NONPOWERED |
| Product Code | KQW |
| Date Received | 2018-07-17 |
| Model Number | NA |
| Catalog Number | 5484805 |
| Lot Number | RS11M037 |
| Device Expiration Date | 2013-06-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Address | 4340 SWINEA RD MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-17 |