MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-07-23 for BA-320-185 manufactured by .
[5025620]
A bone anchor was installed prior to mri in preparation for laser ablation procedure. It was determined that the pt still had orthodontics and these had to be removed prior to the mri/laser ablation procedure. The bone anchor was inadvertently broken during the process of removing the pts orthodontics prior to the laser ablation. The laser ablation procedure was successfully completed and the entry site was closed at the conclusion of the procedure with a small portion of the bone anchor thread left in pt's bone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005726841-2014-00006 |
| MDR Report Key | 4176259 |
| Report Source | 08 |
| Date Received | 2014-07-23 |
| Date of Report | 2014-07-23 |
| Date of Event | 2014-06-20 |
| Date Mfgr Received | 2014-06-25 |
| Date Added to Maude | 2014-10-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ASHTOK GOWDA |
| Manufacturer Street | 8058 EL RIO ST. |
| Manufacturer City | HOUSTON TX 77054 |
| Manufacturer Country | US |
| Manufacturer Postal | 77054 |
| Manufacturer Phone | 7137410111 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BA-320-185 |
| Generic Name | BONE ANCHOR |
| Product Code | HOA |
| Date Received | 2014-07-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-23 |