MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-05-26 for ANCHOR BOLT-LSB STYLE LSBK1-_X-05 manufactured by Ad-tech Medical Instrument Corp..
[46066723]
On april 25, 2016, ad-tech was made aware that some cranial anchor bolts "snapped" upon removal. Clearer details were received from the customer on (b)(6) 2016. According to the customer, it was stated that "... 7 of the 13mm bolts (lsbk1-bx-05) and 6 of the 21mm bolts (lsbk1-ax-05) were used. The patient was noted to have postictal agitation and was seen pulling at the dressing and depths. Staff described proper technique of the surgeons in removing the intact anchor bolts according to instructions provided. It was not clear if any of the bolts broke during removal with the wrench... For the most part, it was felt the patient's agitation and pulling at the dressing was a primary cause for the breaks... There were 7 bolts in total that were discovered broken. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183456-2016-00004 |
| MDR Report Key | 5683506 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-05-26 |
| Date of Report | 2016-05-26 |
| Date of Event | 2016-04-25 |
| Date Mfgr Received | 2016-04-25 |
| Date Added to Maude | 2016-05-26 |
| 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 | 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 CORP. |
| 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 | 2016-05-26 |
| Catalog Number | LSBK1-_X-05 |
| Lot Number | UNKNOWN |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AD-TECH MEDICAL INSTRUMENT CORP. |
| Manufacturer Address | 1901 WILLIAM STREET RACINE WI 53404 US 53404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-26 |