MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,study report with the FDA on 2020-03-25 for CD HORIZON SPINAL SYSTEM UNK manufactured by Medtronic Sofamor Danek Usa, Inc..
[185036346]
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. Products from multiple manufacturers were implanted during the procedure. Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185036347]
It was reported via clinical study that the patient, diagnosed with back pain, underwent mid lumbar interbody fusion at l5-s1. The patient was implanted with the alleged product along with stryker manufactured tritanium and vitoss. With an onset date of (b)(6) 2019, post-op, the patient experienced worsening of leg pain. The patient had bilateral leg pain sciatica and weakness in right leg. The adverse event was determined to be possibly related to general surgery or lumbar fusion procedure, possibly related to disease, and possibly related to minimally invasive procedure. The outcome of the adverse event is ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00365 |
| MDR Report Key | 9876656 |
| Report Source | FOREIGN,STUDY |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2019-10-22 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2020-03-25 |
| 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 | 2020-03-25 |