MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-07-28 for KYPHX EXPRESS INFLATABLE BONE TAMP K15A manufactured by Medtronic Spine Llc..
[1234679]
A pt underwent a single-level kyphoplasty procedure at level t8. It was reported that when filling the vertebra with cement on the right side, the balloon on the pt's left side remained in place. When the physician deflated the balloon on the left side, he had difficulty removing it. When the balloon was finally removed, the treating surgeon noticed cement on the distal tip of the balloon. Additionally, the balloon was separated from the proximal end in the middle. It is believed fragments of the balloon may have remained in the pt. The doctor filled the void with bone cement. The procedure was completed successfully and the pt's status is good.
Patient Sequence No: 1, Text Type: D, B5
[8371748]
Method - device not returned for eval; follow-up info from company representative.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2953769-2009-00083 |
| MDR Report Key | 1486326 |
| Report Source | 05,07 |
| Date Received | 2009-07-28 |
| Date of Report | 2009-06-29 |
| Date of Event | 2009-06-29 |
| Date Mfgr Received | 2009-06-29 |
| Device Manufacturer Date | 2009-04-01 |
| Date Added to Maude | 2010-06-08 |
| 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 | PAMELA SEGALE, SR. DIR. |
| 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 |
| Generic Name | INFLATABLE BONE TAMP |
| Product Code | HXG |
| Date Received | 2009-07-28 |
| Model Number | NA |
| Catalog Number | K15A |
| Lot Number | 01021999 |
| ID Number | NA |
| Device Expiration Date | 2011-04-30 |
| 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 | 2009-07-28 |