MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-11 for LSB ANCHOR BOLT LSB-AX-06 LSBK1-AX-06 manufactured by Ad-tech Medical Instrument Corp..
[138355735]
When inserting the anchor bolt, the bolt snapped. Part of the bolt was impaled into the cranium. A needle driver was used to secure the anchor bolt and unscrew it and remove it entirely.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8407228 |
| MDR Report Key | 8407228 |
| Date Received | 2019-03-11 |
| Date of Report | 2019-02-28 |
| Date of Event | 2019-02-26 |
| Report Date | 2019-03-08 |
| Date Reported to FDA | 2019-03-08 |
| Date Reported to Mfgr | 2019-03-11 |
| Date Added to Maude | 2019-03-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LSB ANCHOR BOLT |
| Generic Name | ELECTRODE, DEPTH |
| Product Code | GZL |
| Date Received | 2019-03-11 |
| Model Number | LSB-AX-06 |
| Catalog Number | LSBK1-AX-06 |
| Lot Number | 0121088 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AD-TECH MEDICAL INSTRUMENT CORP. |
| Manufacturer Address | 400 W OAKVIEW PKWY OAK CREEK WI 53154 US 53154 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-11 |