MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-11-20 for KYPHX LATITUDE II CURETTE A11E manufactured by Medtronic Spine Llc..
[1035921]
During a kyphoplasty procedure, the surgeon used a curette. The break-away safety mechanism of the curette was activated and the surgeon noted resistance upon removal of the curette. A small portion of the curette remained in the vertebral body. The procedure was completed with no patient adverse event.
Patient Sequence No: 1, Text Type: D, B5
[8157223]
Method - follow up with company representative.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2953769-2008-00057 |
| MDR Report Key | 1290905 |
| Report Source | 05,07 |
| Date Received | 2008-11-20 |
| Date of Report | 2008-10-22 |
| Date of Event | 2008-10-22 |
| Date Added to Maude | 2010-05-29 |
| 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 | PAMELA SEGALE, 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KYPHX LATITUDE II CURETTE |
| Generic Name | ORTHOPEDIC CURETTE |
| Product Code | FZS |
| Date Received | 2008-11-20 |
| Model Number | NA |
| Catalog Number | A11E |
| Lot Number | J8030514 |
| ID Number | NA |
| Device Expiration Date | 2009-03-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2008-11-20 |