MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-06-29 for KYPHX LATITUDE II CURETTE, 8.5 MM WEDGE TIP A11E manufactured by Kyphon, Inc..
[635388]
During a balloon kyphoplasty procedure, one of the flanges on the curette head broke off. The treating physician did not attempt to remove the piece and entombed it within bone cement in the patient's vertebral body. The physician reported there was no adverse health effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
[7971445]
Returned product evaluation ; follow up conversation with reporting physician. Results: 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. Kyphon currently markets the kyphx latitude curette (product numbers a11b, c, d and e) for use during balloon kyphoplasty. The curette is intended for scraping or scoring of bone in the spine. The following description if event was noted: curette broke while using it. Piece of it left inside the vertebral body. There was contact with pt. No injury or death to pt. No adverse effect. Sales rep will be returning product. The device was returned for eval in june 2007. The device was confirmed to be the kyphx latitude curette. However, the lot number and expiration date of the lot were unavailable in the action request form. One of the flanges on the distal end of the curette head was separated from the curette. See figure 1 for illustration of the field returned curette. The tip was visually inspected under 10-40x power. The tip of the curette was retained on the loop wire, which is consistent with design. The tip was fully intact and not damaged. However, the curette pin that was inserted through the tip and welded to the flanges was missing. One of the flanges on the curette head broke off, as shown in figure2. The score line ("safety grove") was intact, not broken. See figure 3, curette metal assembly. The score line is designed to separated when the physician rotates the handle and exceeds a predetermined torque value. Separation at the score line limits the amount of torque applied to the distal end of the curette, which minimizes the likelihood of a device failure to occur, such as the bending or breaking of the distal tip. It could not be determined if excessive force was applied to the curette during the procedure. The cause of the breakage is unknown. The physical appearance of the field returned curette was consistent with the complaint documentation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2953769-2007-00028 |
| MDR Report Key | 873565 |
| Report Source | 05,07 |
| Date Received | 2007-06-29 |
| Date of Report | 2007-05-30 |
| Date of Event | 2007-05-30 |
| Date Mfgr Received | 2007-05-30 |
| Date Added to Maude | 2007-12-27 |
| 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 | LAURENCE WALLMAN, 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KYPHX LATITUDE II CURETTE, 8.5 MM WEDGE TIP |
| Generic Name | ORTHOPEDIC CURETTE |
| Product Code | FZS |
| Date Received | 2007-06-29 |
| Returned To Mfg | 2007-06-08 |
| Model Number | NA |
| Catalog Number | A11E |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 938158 |
| Manufacturer | KYPHON, INC. |
| Manufacturer Address | 1221 CROSSMAN AVENUE SUNNYVALE CA 94089 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-06-29 |