MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2012-09-28 for LEKSELL ANCHOR BOLT LSB-AN-05 manufactured by Ad-tech Medicla Instrumetn Corporation.
[18062486]
Two (2) anchor bolts broke during insertion. The doctor reported that the pt was not compromised and the bolts were removed. Surgery was prolonged by two (2) hours.
Patient Sequence No: 1, Text Type: D, B5
[18423429]
The doctor had a problem with the twist drill and screw driver bending which affected the placement of the bolts. Two anchor bolts breaking were the results of these issues. The doctor believes the breaking is due to the bending of the screw driver while placing the bolts. Ad-tech has determined that the drill and placement wrench were not used with a guide tube to properly place the bolts, thus creating an uneven torque which could cause stress on the bolt. The screwdriver was used to remove the bolts, and the doctor was unconcerned at removing the bolts as they already had access through the skull to place the electrodes. The electrodes were sutured in place, and the doctor reported that the pt was not compromised. No permanent damage to pt, no serious injury and no further surgery was required due to the malfunction. The customer was unable to provide ad-tech with the lot numbers for the anchor bolts. The decision to file this adverse event report is the result of a re-review of complaint files.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183456-2012-00005 |
| MDR Report Key | 2768567 |
| Report Source | 00,01 |
| Date Received | 2012-09-28 |
| Date Mfgr Received | 2011-03-03 |
| Date Added to Maude | 2013-01-16 |
| 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 | LISA THEAMA |
| 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 | 2012-09-28 |
| Model Number | LSB-AN-05 |
| Catalog Number | LSB-AN-05 |
| Lot Number | UNK |
| 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 MEDICLA INSTRUMETN CORPORATION |
| Manufacturer Address | RACINE WI 53404 US 53404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-28 |