MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,02,05,07 report with the FDA on 2010-09-24 for KYPHX INFLATABLE BONE TAMP UNK manufactured by Medtronic Spine Llc.
[1427288]
It was reported that a post market clinical study, pt study underwent a balloon kyphoplasty procedure on (b)(6) 2007. One day post procedure, the pt experienced a superficial would infection in three out of four incisions at the incision site which was treated with antibiotics. Reportedly, the event resolved on (b)(6) 2007. No additional info was reported.
Patient Sequence No: 1, Text Type: D, B5
[8781122]
Method: device not returned; followed up with company representative.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2953769-2010-00516 |
| MDR Report Key | 1846243 |
| Report Source | 01,02,05,07 |
| Date Received | 2010-09-24 |
| Date of Report | 2008-05-09 |
| Date of Event | 2007-09-13 |
| Date Mfgr Received | 2008-05-09 |
| 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 AVE. |
| 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 INFLATABLE BONE TAMP |
| Generic Name | INFLATABLE BONE TAMP |
| Product Code | HXG |
| Date Received | 2010-09-24 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| 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 AVE. SUNNYVALE CA 94089 US 94089 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-09-24 |