MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-07-26 for CURETTE, ANGLED, 5-0, 229 MM * R-0374 manufactured by Logan Instruments Inc..
[671599]
The user facility reported during a spinal procedure in 2007, the physician had the tip of the device break off inside the patient. Additional information: the device was purchased in 2003. It was observed the device broke during the surgery, and the time surgery had to be extended could not be determined.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2430952-2007-00015 |
| MDR Report Key | 888826 |
| Date Received | 2007-07-26 |
| Date of Report | 2007-06-08 |
| Date of Event | 2007-04-10 |
| Date Facility Aware | 2007-05-09 |
| Report Date | 2007-06-08 |
| Date Added to Maude | 2007-08-06 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CURETTE, ANGLED, 5-0, 229 MM |
| Generic Name | SURGICAL INSTRUMENT |
| Product Code | FZS |
| Date Received | 2007-07-26 |
| Model Number | * |
| Catalog Number | R-0374 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 866348 |
| Manufacturer | LOGAN INSTRUMENTS INC. |
| Manufacturer Address | * EVERETTE MA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-07-26 |