MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-07-29 for BONOPTY BONE BIOPSY SYSTEM * 17840050 manufactured by Angiomed Gmbh & Co. Medizintechnik Kg.
[435442]
The needle tip broke when performing a bone biopsy in the pt's back. This occurred on the initial twist. The pt is undergoing surgery to remove the broken tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681442-2005-00060 |
| MDR Report Key | 623497 |
| Report Source | 06 |
| Date Received | 2005-07-29 |
| Date of Report | 2005-07-01 |
| Date of Event | 2005-07-01 |
| Date Mfgr Received | 2005-07-01 |
| Device Manufacturer Date | 2004-10-01 |
| Date Added to Maude | 2005-08-02 |
| 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 | 3 |
| Manufacturer Contact | CINDI WALCOTT |
| Manufacturer Street | 1625 WEST 3RD ST. P.O. BOX 1740 |
| Manufacturer City | TEMPE AZ 852801740 |
| Manufacturer Country | US |
| Manufacturer Postal | 852801740 |
| Manufacturer Phone | 4808949515 |
| Manufacturer G1 | ANGIOMED GMBH & CO., MEDIZINTE 9681442 |
| Manufacturer Street | WACHHAUSSTRASSE 6 |
| Manufacturer City | KARLSRUHE 76227 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 76227 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BONOPTY BONE BIOPSY SYSTEM |
| Generic Name | BONE BIOPSY NEEDLE |
| Product Code | LWE |
| Date Received | 2005-07-29 |
| Returned To Mfg | 2005-07-14 |
| Model Number | * |
| Catalog Number | 17840050 |
| Lot Number | 96JO0192 |
| ID Number | * |
| Device Expiration Date | 2007-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 613142 |
| Manufacturer | ANGIOMED GMBH & CO. MEDIZINTECHNIK KG |
| Manufacturer Address | * KARLSRUHE GM |
| Baseline Brand Name | BONOPTY BONE BIOPSY SYSTEM |
| Baseline Generic Name | BONE BIOPSY NEEDLE |
| Baseline Model No | * |
| Baseline Catalog No | 17840050 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-07-29 |