MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-08-27 for BA-320-185 manufactured by Biotex Medical.
[4720587]
Following completion of procedure, it was discovered during anchor bolt removal that the anchor bolt was broken. The break was at the point of attachment of threads. The surgeon opted to leave in the small plastic threads in place rather than remove.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005726841-2014-00007 |
| MDR Report Key | 4102325 |
| Report Source | 08 |
| Date Received | 2014-08-27 |
| Date of Report | 2014-08-27 |
| Date of Event | 2014-07-28 |
| Date Mfgr Received | 2014-07-28 |
| Date Added to Maude | 2014-09-26 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 8058 EL RIO |
| 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 | 2014-08-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOTEX MEDICAL |
| Manufacturer Address | HOUSTON TX 77054 US 77054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-27 |