MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-12-15 for KYPHX BONE BIOSPY DEVICE F05A manufactured by Kyphon, Inc..
[350902]
Patient being treated for a l1 partially healed traumatic fracture. The surgeon gained access to the vertebral body without difficulty using a transpedicular approach. He decided to take a bone biopsy during the procedure. All though the product instruction for use instructs not to mallet the bone biopsy tool, the surgeon used a mallet to aid in its insertion as is his practice with other instruments. The biopsy tool became wedged into a portion of the hard superior endplate that had been displaced downward into the body of the vertebra as a result of the original trauma. While attempting to remove the biopsy tool, it broke and a piece remained in the patient. Radiographs confirmed that the fragment of the bone biopsy device was completely within the boundaries of the vertebral body. The procedure was completed without difficulty and the instrument fragment was encased in the bone cement and there were no clinical sequelae.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2953769-2003-00011 |
| MDR Report Key | 501910 |
| Report Source | 05 |
| Date Received | 2003-12-15 |
| Date of Report | 2003-11-12 |
| Date of Event | 2003-11-12 |
| Date Mfgr Received | 2003-11-12 |
| Device Manufacturer Date | 2003-08-01 |
| Date Added to Maude | 2003-12-22 |
| 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 | RICHARD MOTT, CEO |
| Manufacturer Street | 1350 BORDEAUX DRIVE |
| Manufacturer City | SUNNYVALE CA 94089 |
| Manufacturer Country | US |
| Manufacturer Postal | 94089 |
| Manufacturer Phone | 4085486500 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KYPHX BONE BIOSPY DEVICE |
| Generic Name | BONE BIOPSY DEVICE |
| Product Code | MJG |
| Date Received | 2003-12-15 |
| Model Number | NA |
| Catalog Number | F05A |
| Lot Number | 03071803 |
| ID Number | NA |
| Device Expiration Date | 2004-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 490699 |
| Manufacturer | KYPHON, INC. |
| Manufacturer Address | 1350 BORDEAUX DR. SUNNYVALE CA 94089 US |
| Baseline Brand Name | KYPHX BONE BIOPSY DEVICE |
| Baseline Generic Name | NA |
| Baseline Model No | NA |
| Baseline Catalog No | F05A |
| Baseline ID | NA |
| Baseline Device Family | BONE BIOPSY DEVICE |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2003-12-15 |