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 2018-09-17 for X-STOP INTERSPINOUS SPACER 1-2212 manufactured by Medtronic Sofamor Danek Usa, Inc.
[120380180]
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[120380181]
It was reported that the patient underwent treatment at l4/l5 levels. Post-operatively, the patient began to experience recurrence of neurogenic claudication. Diagnostic image studies revealed displacement of the spacer from the interlaminary space. As a result, a revision surgery was performed for removal followed by lumbar decompression and implantation of a new spacer. The alleged spacer was removed by loosening the locking screws on one of the wing clamps and removed in two pieces and reportedly intact. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2018-01246 |
| MDR Report Key | 7880043 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-17 |
| Date of Report | 2019-02-05 |
| Date Mfgr Received | 2019-01-09 |
| Date Added to Maude | 2018-09-17 |
| 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 | 3 |
| Brand Name | X-STOP INTERSPINOUS SPACER |
| Generic Name | PROSTHESIS, SPINOUS PROCESS SPACER/PLATE |
| Product Code | NQO |
| Date Received | 2018-09-17 |
| Returned To Mfg | 2018-12-10 |
| Model Number | NA |
| Catalog Number | 1-2212 |
| Lot Number | 2275781 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2018-09-17 |