MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-12-21 for NUCLEOTOME 23500 manufactured by Clarus Medical, Llc..
[375837]
During procedure the tip of the nucleotome probe device broke off in the interveteral disc (lumbar) of the patient. At the time of this report the tip remains in the disc. The sales rep. Reports that the patient has been informed and that the physician is working with the patient. There is no indication that the patient has been injured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183911-2005-00001 |
| MDR Report Key | 567384 |
| Date Received | 2005-12-21 |
| Date of Report | 2005-12-19 |
| Date of Event | 2005-10-25 |
| Device Manufacturer Date | 2005-07-01 |
| Date Added to Maude | 2005-01-26 |
| 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 Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Manufacturer Phone | ** |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUCLEOTOME |
| Generic Name | AUTOMATED PERCUTANEOUS DISCECTOMY |
| Product Code | LBK |
| Date Received | 2005-12-21 |
| Returned To Mfg | 2005-12-05 |
| Model Number | 23500 |
| Catalog Number | 23500 |
| Lot Number | 503479 |
| ID Number | NA |
| Device Expiration Date | 2007-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 557196 |
| Manufacturer | CLARUS MEDICAL, LLC. |
| Manufacturer Address | * MINNEAPOLIS MN * US |
| Baseline Brand Name | NUCLEOTOME |
| Baseline Generic Name | AUTOMATED PERCUTANEOUS DISCECTOMY |
| Baseline Model No | 23500 |
| Baseline Catalog No | 23500 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-12-21 |