MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-02-17 for KYPHX INFLATABLE BONE TAMP UNK manufactured by Medtronic Spine Llc..
[1029959]
It was reported that during a single-level kyphoplasty at level t7, the physician inflated the inflatable bone tamp in an osteoporotic patient then noticed a fracture in the vertebral body directly above the treated level. It was reported that after waking up from the procedure, the patient developed progressive paraplegia over a period of a couple of hours. A ct scan of t8 was normal; there was no evidence of cement extravasation. At level t7 bone fragment in the spinal canal was noted, perforating the spinal cord (angle of 35 degrees).
Patient Sequence No: 1, Text Type: D, B5
[8148807]
Device not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2953769-2009-00011 |
| MDR Report Key | 1321542 |
| Report Source | 05,07 |
| Date Received | 2009-02-17 |
| Date of Report | 2009-01-22 |
| Date of Event | 2006-01-01 |
| Date Mfgr Received | 2009-01-22 |
| Date Added to Maude | 2009-02-27 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | PAMELA SEGALE, 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 | 2009-02-17 |
| 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 | 2009-02-17 |