MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2020-02-05 for UNK manufactured by Medtronic Sofamor Danek Usa, Inc..
[187390154]
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
[187390155]
Total patients involved: 14 patients (08 male and 06 female) underwent revision surgery after bkp and 105 (21 male and 84 female) consecutive patients underwent single bkp, age: 79. 7 years (mean age). It was reported via literature titled " characteristic radiological findings for revision surgery after balloon kyphoplasty" post-op, a total of 120 patients in which 14 patients underwent revision surgery after balloon kyphoplasty (bkp). Radiographs revealed cement dislodgement to the anterior and a fracture of the caudal vertebral body (l2). Revision surgery was performed for uncontrolled back pain or neurological deficit after bkp, due to cement dislodgement, recollapse of the vertebra, and adjacent vertebral fracture. An l1 corpectomy was performed, with autografting and posterior fixation from t10 to l3. The clinical reasons for revision surgery included back pain in 13 patients and leg pain in 1 patient. Posterior fusion was performed in 10 patients. Anterior and posterior fusion were performed in 4 patients for cement dislodgement repair. During posterior fusion, posterior instrumentation and bone grafting were performed, without cement removal. In anterior and posterior fusion, cement removal and bone grafting were performed, using an anterior approach, and posterior instrumentation was added. Adverse events: pedicle fracture of the caudal vertebral body (l2), and posterior wall injury, split type fracture, back pain, leg pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00144 |
| MDR Report Key | 9669884 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-05 |
| Date Mfgr Received | 2020-01-11 |
| Date Added to Maude | 2020-02-05 |
| 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 85281 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85281 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CEMENT, BONE, VERTEBROPLASTY |
| Product Code | NDN |
| Date Received | 2020-02-05 |
| 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 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-05 |