MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2006-04-03 for MICRO BUR, HEAVY GRIT DIAMOND UNK manufactured by Conmed Linvatec Corp..
[16031250]
It was reported that a pt received a post operative infection following a cervical laminoplasty and thoracic laminectomy. The user facility reported that the infection may be related to a micro bur used in this procedure. In addition, the user facility reported that the micro bur used in this surgery may be one identified in a recent recall. The pt's wound was cultured and the infection was identified as mrsa. Pt discharged from hosp in 2006 with crutch walking condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017294-2006-00110 |
| MDR Report Key | 695766 |
| Report Source | 01,06,07 |
| Date Received | 2006-04-03 |
| Date of Report | 2006-03-10 |
| Date of Event | 2005-10-06 |
| Date Mfgr Received | 2006-03-10 |
| Date Added to Maude | 2006-04-06 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | BEVERLY SCHANER |
| Manufacturer Street | 11311 CONCEPT BLVD |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995169 |
| Manufacturer G1 | CONMED LINVATEC CORP |
| Manufacturer Street | 11311 CONCEPT BLVD |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICRO BUR, HEAVY GRIT DIAMOND |
| Generic Name | BUR |
| Product Code | GPF |
| Date Received | 2006-04-03 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 684880 |
| Manufacturer | CONMED LINVATEC CORP. |
| Manufacturer Address | * LARGO FL * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2006-04-03 |