MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-07 for R-C 8MM UNK manufactured by Lenox Maclaren.
[273834]
The pt was diagnosed with progressive, severe l5 radiculopathy and was undergoing spinal surgery in 2003. During the procedure, the surgeon noted that, while using the angled ring curette, its tip "snapped" off, but he was able to retrieve the fragments. No remnant of the defective instrument remained in the surgical wound. The pt was not placed at risk of harm, nor was the length of the surgery extended because of this event. The defective instrument and its loose fragments (about 3/4 -inch in length) were sent to risk management for safekeeping.
Patient Sequence No: 1, Text Type: D, B5
[302583]
Add'l info rec'd from mfr 8/19/03: repair request: surgeon requested replacement with new instrument. Improper use: instrument appears to have been over powered by user. This instrument was made as a special request from the surgeon. As co was not allowed to evaluate the physical instrument. It is unable to determine the use, or sharpening history. The instrument appears from the photo copy that the delicate tip was over powered by the user. Please note that this is a custom-made device for the individual surgeon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1028911 |
| MDR Report Key | 470562 |
| Date Received | 2003-07-07 |
| Date of Report | 2003-06-24 |
| Date of Event | 2003-06-17 |
| Date Added to Maude | 2003-07-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | R-C 8MM |
| Generic Name | RING CURETTE (ANGLED) |
| Product Code | FZS |
| Date Received | 2003-07-07 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | R-C 8MM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 459402 |
| Manufacturer | LENOX MACLAREN |
| Manufacturer Address | 657 S TAYLOR AVE, #A LOUISVILLE CO 80027 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-07-07 |