MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-04-23 for KYPHX LATITUDE II CURETTE 6.5MM WEDGE TIP A11D manufactured by Medtronic Spine Llc.
[14872572]
It was reported a physician performed a kyphoplasty procedure on a pt to treat level t12. During the procedure, an expired curette was used in the pt. No additional info was reported.
Patient Sequence No: 1, Text Type: D, B5
[15167592]
Device not returned, follow up with company rep.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2953769-2010-00176 |
| MDR Report Key | 1675840 |
| Report Source | 05,07 |
| Date Received | 2010-04-23 |
| Date of Report | 2010-03-15 |
| Date of Event | 2010-03-15 |
| Date Mfgr Received | 2010-03-15 |
| Device Manufacturer Date | 2007-12-01 |
| Date Added to Maude | 2011-10-05 |
| 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 | MICHAEL ARMSTRONG SR. DIR |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KYPHX LATITUDE II CURETTE 6.5MM WEDGE TIP |
| Generic Name | CURETTE |
| Product Code | HTF |
| Date Received | 2010-04-23 |
| Model Number | NA |
| Catalog Number | A11D |
| Lot Number | J7121927 |
| ID Number | NA |
| Device Expiration Date | 2008-12-31 |
| 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 | 2010-04-23 |