MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-06-09 for KYPHX BONE BIOPSY DEVICE F05A manufactured by Medtronic Spine, Llc..
[1401254]
It was reported that a patient underwent a balloon kyphoplasty procedure. Reportedly on attempt to pull out the bone biopsy device, the taupe-colored handle "ripped off" the aluminum shaft. The physician noted that the patient's vertebral body was very sclerotic and the one biopsy device became stuck in the bone. Pliers were then used to remove the device, causing the shaft to pinch closed. After removing the device from the working cannula, the pinched tip was cut off in an attempt to obtain the vertebral tissue sample by using the bone biopsy plunger. There was no foreign body left in the patient and no adverse event occurred. No add'l info was reported.
Patient Sequence No: 1, Text Type: D, B5
[8578568]
Method - device not returned; followed up with company representative. Conclusion: two most likely factors contributing to breakage of the handle are entrapment of bone particulate between the access cannula and binding of the nozzle tip in the vertebral body, which was caused by deformation of the nozzle tip. The tip of the nozzle was probably deformed in the procedure during the 1st pass. Sclerotic condition of the pt's bone has certainly exacerbated the effects of bone entrapment and markedly contributed to deformation of the nozzle tip.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2953769-2010-00209 |
| MDR Report Key | 1723670 |
| Report Source | 05,07 |
| Date Received | 2010-06-09 |
| Date of Report | 2010-05-12 |
| Date of Event | 2010-05-12 |
| Date Mfgr Received | 2010-05-12 |
| Device Manufacturer Date | 2009-01-01 |
| Date Added to Maude | 2011-01-14 |
| 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 BONE BIOPSY DEVICE |
| Generic Name | BONE BIOPSY DEVICE SIZE 3 |
| Product Code | MJG |
| Date Received | 2010-06-09 |
| Returned To Mfg | 2010-05-18 |
| Model Number | NA |
| Catalog Number | F05A |
| Lot Number | 0001111632 |
| ID Number | NA |
| Device Expiration Date | 2011-01-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2010-06-09 |