MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-04-27 for KERRISON 1 FF771R * manufactured by Aesculap, Inc ..
[1852309]
Removal of disc fragments from behind the vertebral bodies of c6 and c7 was carried out with a blunt nerve hook and kerrison punches 1 and 2 mm. While removing this large disc fragment, i realized that the small tip of a 1mm kerrison punch was actually missing from the instrument. Obviously this was broken and i suspected it was trapped behind a vertebral body. So intraoperative x-ray were taken, confirming that the small metallic fragment was behind the vertebral body of c6 and migrated laterally. I attempted several times with a blunt long nerve hook to retrieve the fragment, but it was impossible to go beyond a certain point without exerting too much pressure and risking to damage the spinal cord. Since this small fragment was not causing any compression of the spinal cord or any distortion, i believed it was reasonable to leave it in place rather than trying to mobilize it with blunt instruments.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2074168 |
| MDR Report Key | 2074168 |
| Date Received | 2011-04-27 |
| Date of Report | 2011-04-27 |
| Date of Event | 2011-04-20 |
| Report Date | 2011-04-27 |
| Date Reported to FDA | 2011-04-27 |
| Date Added to Maude | 2011-05-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| 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 | KERRISON 1 |
| Generic Name | RONGEUR, POWERED |
| Product Code | HAD |
| Date Received | 2011-04-27 |
| Model Number | FF771R |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP, INC . |
| Manufacturer Address | 3773 CORPORATE PKWY. CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-27 |