MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-09-24 for KYPHX LATITUDE II CURETTE 8.0MM T-TIP A11B manufactured by Medtronic Spine Llc.
[15144013]
It was reported that a pt underwent a kyphoplasty procedure on (b)(6) 2007 at t7 and l2. During the procedure, an expired curette was used in the pt. There were no pt complications or adverse events reported. No additional info was reported.
Patient Sequence No: 1, Text Type: D, B5
[15454078]
Method - device not returned, follow up with company representative. Product was from trunk stock.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2953769-2010-00454 |
| MDR Report Key | 1846997 |
| Report Source | 07 |
| Date Received | 2010-09-24 |
| Date of Report | 2009-09-11 |
| Date of Event | 2007-12-14 |
| Date Mfgr Received | 2009-09-11 |
| Device Manufacturer Date | 2005-11-01 |
| Date Added to Maude | 2011-02-02 |
| 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 | 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KYPHX LATITUDE II CURETTE 8.0MM T-TIP |
| Generic Name | CURETTE |
| Product Code | KAP |
| Date Received | 2010-09-24 |
| Model Number | NA |
| Catalog Number | A11B |
| Lot Number | J5111007 |
| ID Number | NA |
| Device Expiration Date | 2007-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2010-09-24 |