MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-10-01 for ANCHOR BOLT LSBK2-_X-04 manufactured by Ad-tech Medical Instrument Corp..
[27247609]
As stated in the event description section, this issue only occurs during the lateral approach to the hippocampus and amygdala. The bone that is drilled into prior to performing the lateral approach is called the squamous temporal bone. This bone is much thinner and can be only 2-3 mm thick. The complaint investigation team is currently in the process of investigating the potential malfunction.
Patient Sequence No: 1, Text Type: N, H10
[27247610]
On (b)(6) 2015, customer feedback was received related to one of ad-tech's anchor bolt. Specifically, the customer stated that during approximately 50% of the surgeries involving the lateral approach to the hippocampus and amygdala, they have experienced that the anchor bolt does not hold well when the entry point is over a "thin" squamous temporal bone. The anchor bolt gets very little purchase and is very loose, potentially causing the electrode to move. The customer also noted that if the squamous temporal bone is thick, the anchor bolt holds well. This is considered a potential malfunction; however, there have been no reports of patient harm when this type of instance occurs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183456-2015-00008 |
| MDR Report Key | 5117630 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-10-01 |
| Date of Report | 2015-09-01 |
| Date Mfgr Received | 2015-09-01 |
| Date Added to Maude | 2015-10-01 |
| 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 |
| Generic Name | ANCHOR BOLT |
| Product Code | GCZ |
| Date Received | 2015-10-01 |
| Catalog Number | LSBK2-_X-04 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| 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 | 2015-10-01 |