MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-04-04 for LEKSELL ANCHOR BOLT LSB-BX-04 manufactured by Ad-tech Medical Instrument Corp..
[20647014]
Multiple anchor bolts were placed in a pediatric patient (actual number unknown). One of the anchor bolts broke while the patient was in an agitated state. The neurosurgeon had to remove the broken piece (threads) surgically. It was reported that patient monitoring was not affected and there was no negative patient outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183456-2013-00002 |
| MDR Report Key | 3042825 |
| Report Source | 00 |
| Date Received | 2013-04-04 |
| Date of Report | 2013-04-04 |
| Date of Event | 2013-03-07 |
| Date Mfgr Received | 2013-03-07 |
| Date Added to Maude | 2013-06-03 |
| 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 Street | 1901 WILLIAM ST. |
| Manufacturer City | RACINE WI 53404 |
| Manufacturer Country | US |
| Manufacturer Postal | 53404 |
| Manufacturer Phone | 2626341555 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEKSELL ANCHOR BOLT |
| Generic Name | ANCHOR BOLT |
| Product Code | GYC |
| Date Received | 2013-04-04 |
| Model Number | LSB-BX-04 |
| Catalog Number | LSB-BX-04 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AD-TECH MEDICAL INSTRUMENT CORP. |
| Manufacturer Address | RACINE WI 53404 US 53404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-04 |