MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,study report with the FDA on 2020-02-05 for KYPHON XPEDE BONE CEMENT CX01A manufactured by Medtronic Sofamor Danek Usa, Inc.
[177951976]
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
[177951977]
It was reported via clinical study that the patient underwent a surgery, in which the alleged cement was implanted. On (b)(6) 2020, post-op, patient suffered with chest pain and back pain. Tenderness at the surgical site was noted. According to the investigator, this event was possibly related to procedure, bone cement and any other components used during the procedure. This event was not related to underlying condition or disease. Actions taken due to this adverse event included prolonged hospitalization of an existing hospitalization on (b)(6) 2020. The outcome of this adverse event is not recovered.
Patient Sequence No: 1, Text Type: D, B5
[188142879]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188142880]
There was prolonged hospitalization of an existing hospitalization from (b)(6) 2020 to (b)(6) 2020 due to the reported adverse event. Onset date of the adverse event was (b)(6) 2020. The adverse event was first determined to be a serious adverse event on (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00147 |
| MDR Report Key | 9672411 |
| Report Source | FOREIGN,STUDY |
| Date Received | 2020-02-05 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-02-19 |
| 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 |
| 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 | 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 | KYPHON XPEDE BONE CEMENT |
| Generic Name | CEMENT, BONE, VERTEBROPLASTY |
| Product Code | NDN |
| Date Received | 2020-02-05 |
| Model Number | NA |
| Catalog Number | CX01A |
| Lot Number | EL70025 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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. Other | 2020-02-05 |