MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-09-09 for KYPHX EXPRESS INFLATABLE BONE TAMP 15/2 K15B manufactured by Medtronic Spine Llc..
[21319609]
Other; device not returned for evaluation; follow-up information from company representative. The filing of this report does not constitute an admission that any device discussed herein caused or contributed to a reportable event.
Patient Sequence No: 1, Text Type: N, H10
[21379815]
During a balloon kyphoplasty procedure, it was reported that the balloon ruptured. It was reported the balloon tore as the physician was removing the balloon. Part of the balloon remained in the vertebral body. To date per the report, the patient has not experienced any adverse sequela.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2953769-2008-00040 |
| MDR Report Key | 1157192 |
| Report Source | 07 |
| Date Received | 2008-09-09 |
| Date of Report | 2008-08-18 |
| Date of Event | 2008-08-18 |
| Date Mfgr Received | 2008-08-18 |
| Date Added to Maude | 2009-07-21 |
| 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 | LAURENCE WALLMAN, 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 EXPRESS INFLATABLE BONE TAMP 15/2 |
| Generic Name | INFLATABLE BONE TAMP |
| Product Code | HXG |
| Date Received | 2008-09-09 |
| Model Number | NA |
| Catalog Number | K15B |
| 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 | 2008-09-09 |