MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-09-24 for KYPHX XPANDER INFLATABLE BONE TAMP, 15/3 K09A manufactured by Medtronic Spine Llc.
[21012804]
It was reported by a physician who performed two kyphoplasty procedures that: two patients developed fevers approximately 12 hours post-operatively. Both were tested for sepsis. Neither patients developed wound infections. The evaluation for sepsis were negative for both patients. The patients were started on antibiotics until the results of the cultures were available. The fevers resolved after 48 hours. The source of the fevers were not identified. The patients were discharged home. No additional information was reported.
Patient Sequence No: 1, Text Type: D, B5
[21204367]
Method; device not returned, follow up with representative.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2953769-2010-00479 |
| MDR Report Key | 1846251 |
| Report Source | 05,07 |
| Date Received | 2010-09-24 |
| Date of Report | 2006-03-16 |
| Date of Event | 2006-03-08 |
| Date Mfgr Received | 2006-03-16 |
| Date Added to Maude | 2010-09-30 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL ARMSTRONG, SR. DIRECTOR |
| Manufacturer Street | 1221 CROSSMAN AVENUE |
| Manufacturer City | SUNNYVALE CA 94089 |
| Manufacturer Country | US |
| Manufacturer Postal | 94089 |
| Manufacturer Phone | 4085486500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KYPHX XPANDER INFLATABLE BONE TAMP, 15/3 |
| Generic Name | INFLATABLE BONE TAMP |
| Product Code | HXG |
| Date Received | 2010-09-24 |
| Model Number | NA |
| Catalog Number | K09A |
| Lot Number | J6020202 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SPINE LLC |
| Manufacturer Address | 1221 CROSSMAN AVENUE SUNNYVALE CA 94089 US 94089 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-09-24 |