MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-11-03 for KYPHX INFLATABLE BONE TAMP UNK manufactured by Medtronic Spine Llc.
[1243517]
It was reported that a patient, with a thoracic fracture and some pre-operative bone retropulsion in the canal, underwent a kyphoplasty procedure. An increase in the amount of bone retropulsion post-operatively was observed, and the patient suffered some neurological deficits. The physician performed a decompression surgery and the neurologic deficits resolved. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
[8360508]
Device not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2953769-2009-00166 |
| MDR Report Key | 1522851 |
| Report Source | 05,07 |
| Date Received | 2009-11-03 |
| Date of Report | 2009-10-09 |
| Date Mfgr Received | 2009-10-09 |
| Date Added to Maude | 2009-11-12 |
| 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 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KYPHX INFLATABLE BONE TAMP |
| Generic Name | INFLATABLE BONE TAMP |
| Product Code | HXG |
| Date Received | 2009-11-03 |
| 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. Required No Informationntervention | 2009-11-03 |