MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2003-08-20 for CUSHING RONGEUR KM 47-732 manufactured by Kmedic.
[293069]
The upper jaw of a cusing rongeur fractured during a l5-si partial discectomy procedure. The surgeon was unable to retrieve the fractured piece without causing risk to the patient. An x-ray confirmed that the fractured piece remained in the patient. The specific location of the fractured piece is unknown to kmedic the patient's condition is stable and has been released 07/03.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2434296-2003-00002 |
| MDR Report Key | 478926 |
| Report Source | 06 |
| Date Received | 2003-08-20 |
| Date of Report | 2003-07-25 |
| Date of Event | 2003-07-21 |
| Date Mfgr Received | 2003-07-25 |
| Device Manufacturer Date | 1999-01-01 |
| Date Added to Maude | 2003-08-22 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DANDENIA ZABAT |
| Manufacturer Street | 190 VETERANS DR |
| Manufacturer City | NORTHVALE NJ 07647 |
| Manufacturer Country | US |
| Manufacturer Postal | 07647 |
| Manufacturer Phone | 2017674002 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUSHING RONGEUR |
| Generic Name | INTERVERTEBRAL DISC RONGEUR |
| Product Code | EMH |
| Date Received | 2003-08-20 |
| Model Number | KM 47-732 |
| Catalog Number | KM 47-732 |
| Lot Number | V/C: UNK D/C: 99/1 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 467739 |
| Manufacturer | KMEDIC |
| Manufacturer Address | 190 VETERANS DR. NORTHVALE NJ 07647 US |
| Baseline Brand Name | CUSHING RONGEUR 7" UP, 2X10MM |
| Baseline Generic Name | INTERVERTEBRAL DISC RONGEUR |
| Baseline Model No | KM 47-732 |
| Baseline Catalog No | KM 47-732 |
| Baseline ID | NA |
| Baseline Device Family | RONGEUR |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-08-20 |