MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-01-18 for RADIONICS DA (2.7) manufactured by Radionics.
[15711746]
During sterotactic brain biopsy drill bit tip broke off in cranium. Surgeon was using a hand held non-motorized twist drill. Tip was surgically removed and patient made a fill recovery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222895-2002-00001 |
| MDR Report Key | 372543 |
| Report Source | 05 |
| Date Received | 2002-01-18 |
| Date of Report | 2002-01-18 |
| Date of Event | 2001-06-21 |
| Date Mfgr Received | 2001-11-20 |
| Date Added to Maude | 2002-01-24 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | AMY ROCHE |
| Manufacturer Street | 22 TERRY AVE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal | 01803 |
| Manufacturer Phone | 7812721233 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RADIONICS |
| Generic Name | DRILL ASSEMBLY 2.7 MM |
| Product Code | HBG |
| Date Received | 2002-01-18 |
| Model Number | DA (2.7) |
| Catalog Number | DA (2.7) |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 361667 |
| Manufacturer | RADIONICS |
| Manufacturer Address | 22 TERRY AVE BURLINGTON MA 01803 US |
| Baseline Brand Name | RADIONICS |
| Baseline Generic Name | DRILL ASSEMBLY 2.7MM |
| Baseline Model No | DA(2.7) |
| Baseline Catalog No | DA(2.7) |
| Baseline ID | NA |
| Baseline Device Family | DRILL ASSEMBLY |
| 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 | 2002-01-18 |