MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-08-18 for KYPHX BONE BIOPSY DEVICE F05A manufactured by Kyphon, Inc..
[20758274]
During a vertebral body biopsy on a male patient, the physician cored into what was reported as very hard bone and the biopsy device became stuck in the bone. The physician was unable to remove the device per protocol, and when pulling the biopsy device out with the cannula, the device broke at the tip leaving a 1. 5 inch piece of the biopsy device embedded in the vertebral body of the patient. Physician reported no risk to the patient and did attempted to remove the piece of the biopsy device. Physician reported the patient is not experiencing any adverse consequences from the event and does not feel the patient will experience any adverse effects in the future, and is not concerned about the biopsy device tip remaining in the patient's vertebral body.
Patient Sequence No: 1, Text Type: D, B5
[20832265]
Method-other; device not returned for evaluation; follow-up conversation with physician reporting event. Results-other; no conclusion can be drawn. The filing of this report does not constitute an admission that any device discussed herein caused or contributed to a reportable event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2953769-2006-00041 |
| MDR Report Key | 772304 |
| Report Source | 05,07 |
| Date Received | 2006-08-18 |
| Date of Report | 2006-07-20 |
| Date of Event | 2006-07-20 |
| Date Mfgr Received | 2006-07-20 |
| Date Added to Maude | 2006-10-25 |
| 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 | CINDY DOMECUS, VP |
| Manufacturer Street | 1221 CROSSMAN AVENUE |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KYPHX BONE BIOPSY DEVICE |
| Generic Name | BIOPSY NEEDLE |
| Product Code | MJG |
| Date Received | 2006-08-18 |
| Model Number | NA |
| Catalog Number | F05A |
| Lot Number | UNK |
| ID Number | NA |
| 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 | 760088 |
| Manufacturer | KYPHON, INC. |
| Manufacturer Address | 1221 CROSSMAN AVE. 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. Other | 2006-08-18 |