MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-03-17 for CD HORIZON SPINAL SYSTEM UNK manufactured by Medtronic Sofamor Danek Usa, Inc..
[187372411]
Other: outcomes to adverse event: injury [foot drop] although it is unknown whether the product caused or contributed to the reported event, we are filling this mdr for notification purpose. 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
[187372412]
Pt demographics: gender- female, age- (b)(6) years old it was reported via literature titled "based upon 7. 2% of the eligible voting members, the american association of neurological surgeons (aans) suspended dr. (b)(6) for arguing against unnecessarily extensive spine surgery" post-op, the patient was suffering from hypertensive, osteopenia, inactive, obesity with mild radiculopathy attributed to mild/moderate l4-l5 spinal stenosis and grade i degenerative spondylolisthesis (no motion on dynamic x-rays). The patient initially scheduled surgery with dr. (b)(6). She then obtained a second opinion from dr. (b)(6) at the hospital for special surgery and he recommended lumbar laminectomy, without fusion. The patient then scheduled her surgery with dr. (b)(6). Due to a blizzard, the patient? S decompression surgery was postponed, and rescheduled surgery with dr. (b)(6). A few days before the surgery, dr. (b)(6) announced that his younger partner, dr. (b)(6), would perform the surgery. Dr. (b)(6) had never spoken to, or examined, the patient, and he performed a minimally invasive (mi) tlif, not a decompression. As a result of the surgery, the patient woke up with a new, permanent, right-sided foot drop attributed to a stretch injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00316 |
| MDR Report Key | 9842358 |
| Report Source | LITERATURE |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-03-17 |
| 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 | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CD HORIZON SPINAL SYSTEM |
| Generic Name | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
| Product Code | KWP |
| Date Received | 2020-03-17 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC. |
| Manufacturer Address | 1800 PYRAMID PLACE MEMPHIS TN 38132 US 38132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-17 |