MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2001-04-27 for PITUITARY RONGUER UNK-RONGEUR manufactured by Allegiance Healthcare Corp..
[188915]
In 1998, the plaintiff underwent a lumbar laminectomy. The plaintiff alleges that the pituitary rongeur broke apart, causing metal fragments of the instrument to disperse in the operative field. The plainitff further alleges that the defendant did not remove all of the metallic fragments from the plaintiff's back. As a result, the plaintiff alleges they have suffered injury to their spine, its muscles, nerves, discs, and bones, weakness and parathesis of all muscle groups in their low back and lower extremities, sensory impairment of both extremities, weakness and parathesis in their lower left extremity, severe and disabling low back pain, severe emotional and psychological sequela.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2001-00128 |
| MDR Report Key | 329317 |
| Report Source | 07 |
| Date Received | 2001-04-27 |
| Date of Report | 2001-04-27 |
| Date of Event | 1998-09-28 |
| Date Mfgr Received | 2001-04-17 |
| Date Added to Maude | 2001-05-01 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | PATRICIA SHAPRE-GREGG |
| Manufacturer Street | 1500 WAUKEGAN RD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475784148 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PITUITARY RONGUER |
| Generic Name | PITUITARY RONGEUR |
| Product Code | EMH |
| Date Received | 2001-04-27 |
| Model Number | UNK-RONGEUR |
| Catalog Number | UNK-RONGEUR |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 318685 |
| Manufacturer | ALLEGIANCE HEALTHCARE CORP. |
| Manufacturer Address | 1500 WAUKEGAN RD. MCGAW PARK IL 60085 US |
| Baseline Brand Name | PITUITARY RONGEUR |
| Baseline Generic Name | PITUITARY RONGEUR |
| Baseline Model No | UNK-RONGEUR |
| Baseline Catalog No | UNK-RONGEUR |
| Baseline ID | NA |
| Baseline Device Family | INSTRUMENT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-04-27 |