MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-09-14 for ANCHOR BOLT-LSB STYLE LSBK1-AX-05 manufactured by Ad-tech Medical Instrument Corporation.
[86271773]
As stated in the event description, ad-tech was made aware of an issue on (b)(6) 2017. During an seeg/rosa depth case, while attempting to place an anchor bolt for one of the trajectories the bolt broke. The doctor stated that the bone was thick and when attempting to screw the bolt into the bone, some resistance was felt and the wrench started to turn very easily. At this point it was identified that the base of the anchor bolt broke off at the top of the threads. An incision and a slight craniectomy had to be made to retrieve the broken bolt and some of the bolt was left behind. The doctor stated that no serious injury occurred. To date, multiple attempts have been made to obtain additional information. Ad-tech has not received any responses. Although the product was not sent back to ad-tech for evaluation, a picture was sent showing the broken bolt. Based on the picture, the alleged deficiency was confirmed in the complaint. This investigation is still on-going.
Patient Sequence No: 1, Text Type: N, H10
[86271774]
Ad-tech was made aware of an issue on (b)(6) 2017. During an seeg/rosa depth case, while attempting to place an anchor bolt for one of the trajectories the bolt broke. The doctor stated that the bone was thick and when attempting to screw the bolt into the bone, some resistance was felt and the wrench started to turn very easily. At this point it was identified that the base of the anchor bolt broke off at the top of the threads. An incision and a slight craniectomy had to be made to retrieve the broken bolt and some of the bolt was left behind. According to the doctor, there was no serious injury to the patient as a result of this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183456-2017-00007 |
| MDR Report Key | 6867065 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-09-14 |
| Date of Report | 2017-09-14 |
| Date of Event | 2017-08-15 |
| Date Mfgr Received | 2017-08-15 |
| Device Manufacturer Date | 2016-10-12 |
| Date Added to Maude | 2017-09-14 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KATHLEEN BARLOW |
| Manufacturer Street | 1901 WILLIAM STREET |
| Manufacturer City | RACINE WI 53404 |
| Manufacturer Country | US |
| Manufacturer Postal | 53404 |
| Manufacturer Phone | 2626341555 |
| Manufacturer G1 | AD-TECH MEDICAL INSTRUMENT CORPORATION |
| Manufacturer Street | 1901 WILLIAM STREET |
| Manufacturer City | RACINE WI 53404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANCHOR BOLT-LSB STYLE |
| Generic Name | ANCHOR BOLT-LSB STYLE |
| Product Code | GCZ |
| Date Received | 2017-09-14 |
| Catalog Number | LSBK1-AX-05 |
| Lot Number | 208140625 |
| Device Expiration Date | 2018-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AD-TECH MEDICAL INSTRUMENT CORPORATION |
| Manufacturer Address | 1901 WILLIAM STREET RACINE WI 53404 US 53404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-14 |