MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-08-25 for KYPHX BONE BIOPSY DEVICE F05A manufactured by Kyphon, Inc..
[529389]
During a t11 balloon kyphoplasty procedure on an older female pt, a bone biopsy was performed. The physician reported that the handle of the bone biopsy device broke off when he was attempting to extract the biopsy device from the pt. The physician reported that he had difficulty removing the biopsy device through the cannula, but was able to remove the biopsy device and the cannula together. The physician reported that there were no adverse consequences to the pt from the event.
Patient Sequence No: 1, Text Type: D, B5
[7795093]
Device was not returned for eval; no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2953769-2006-00042 |
| MDR Report Key | 775103 |
| Report Source | 05,07 |
| Date Received | 2006-08-25 |
| Date of Report | 2006-07-26 |
| Date of Event | 2006-07-25 |
| Date Mfgr Received | 2006-07-26 |
| Date Added to Maude | 2006-11-02 |
| 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 | 2006-08-25 |
| 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 | 762882 |
| 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 | 2006-08-25 |