MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-05-04 for KYPHX INFLATABLE BONE TAMP UNK manufactured by Medtronic Spine Llc..
[16413502]
During a physician review of the operative report of a multi level kyphoplasty case that occurred in (b) (6), it was reported that the bone "cement was noted all up and down the canal". It was stated in the report that the physician could not see very well, however, still continued with the procedure; and the bone cement reached toothpaste consistency prior to injection. It was also noted that a drill was put through the anterior cortex of the vertebral body, and based on a ct image, there is a clear tract through the canal the same size as the canula. Reportedly, the balloon also ruptured and the contrast traveled everywhere. It is unknown if any balloon fragments were left in the patient or if there was any allergy to the contrast media. The patient was paralyzed. It was confirmed that the bone cement extravasation was reported in mfr report# 2953769-2009-00202 and filed on 12/18/2009. No additional information was reported.
Patient Sequence No: 1, Text Type: D, B5
[16483762]
Method - device not returned, follow up with company representative.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2953769-2010-00178 |
| MDR Report Key | 1674972 |
| Report Source | 05,07 |
| Date Received | 2010-05-04 |
| Date of Report | 2010-04-05 |
| Date of Event | 2008-01-01 |
| Date Mfgr Received | 2010-04-05 |
| Date Added to Maude | 2010-05-10 |
| 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 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 | 2010-05-04 |
| 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 | 2010-05-04 |