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 2020-03-31 for CD HORIZON SPINAL SYSTEM UNK manufactured by Medtronic Sofamor Danek Usa, Inc..
[186752308]
Product was not 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
[186752309]
It was reported that: on (b)(6) 2020: the patient presented with the pre-operative diagnoses of broken rods and pseudoarthrosis. She underwent posterior lumbar fusion with transforaminal lumbar interbody fusion at l3-s1. After 1 week post-op, the patient heard a huge pop. On (b)(6) 2020: ct scan was performed due to right low back pain and pop sound. Impressions: 1. Interval anterior interbody fusion at l4-l5. 2. Posterior instrumentation with interval revision. Interruption involving the right l3 transpedicular screw, possible fracture right l3 transpedicular screw. 3. Mild displaced fracture involving right transverse process of l3, acute, subacute or chronic. The patient also underwent x-rays, which showed top two screws broken on a l3-s1 surgery. On (b)(6) 2020: the patient met with her surgeon to discuss about the revision surgery to be scheduled. The patient was given a back stabilizer and sent home.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00399 |
| MDR Report Key | 9902632 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-18 |
| Date Added to Maude | 2020-03-31 |
| 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 |
| Product Code | NKB |
| Date Received | 2020-03-31 |
| 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. Required No Informationntervention | 2020-03-31 |