MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-09-10 for KYPHX INFLATABLE BONE TAMP UNK manufactured by Medtronic Spine Llc.
[1137715]
A pt underwent a single level balloon kyphoplasty. The balloon on the inflatable bone tamp was left inflated during cement injection on the contralateral side. Medical personnel were initially unaware the balloon was inflated. Upon deflating the balloon, blood was noted in the contrast material - a sign that the balloon had ruptured. The physician had difficulty removing the balloon and used force to remove it. This resulted in the balloon breaking with one of the radiopaque markers from the balloon being left behind. An attempt to retrieve the radiopaque marker was made with no success. It was reported that the case was completed successfully without any pt complications.
Patient Sequence No: 1, Text Type: D, B5
[8474582]
Device not returned. Follow up with company rep.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2953769-2009-00121 |
| MDR Report Key | 1469611 |
| Report Source | 07 |
| Date Received | 2009-09-10 |
| Date of Report | 2009-08-11 |
| Date of Event | 2009-08-11 |
| Date Mfgr Received | 2009-08-11 |
| Date Added to Maude | 2009-09-21 |
| 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 | 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 INFLATABLE BONE TAMP |
| Generic Name | INFLATABLE BONE TAMP |
| Product Code | HXG |
| Date Received | 2009-09-10 |
| 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; 2. Required No Informationntervention | 2009-09-10 |