MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-02-24 for KYPHX XPANDER INFLATABLE BONE TAMP K09A manufactured by Medtronic Spine Llc.
[1076102]
It was reported that during a single level kyphoplasty procedure, the balloon was deflated but could not be removed. The shaft of the balloon broke one inch proximal to the balloon. One inch of the shaft and the entire balloon remained in the patient. The vertebral body was filled with bone cement. The procedure was successful, and it was reported that there was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
[8175829]
Other; device not returned, follow up conversation with company representative and reporting physician.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2953769-2009-00015 |
| MDR Report Key | 1334650 |
| Report Source | 05,07 |
| Date Received | 2009-02-24 |
| Date of Report | 2009-02-05 |
| Date of Event | 2009-02-05 |
| Date Mfgr Received | 2009-02-05 |
| Date Added to Maude | 2009-08-06 |
| 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. DIRECTOR |
| Manufacturer Street | 1221 CROSSMAN AVENUE |
| 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 XPANDER INFLATABLE BONE TAMP |
| Generic Name | INFLATABLE BONE TAMP |
| Product Code | HXG |
| Date Received | 2009-02-24 |
| Model Number | NA |
| Catalog Number | K09A |
| 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 | 2009-02-24 |