MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-12-16 for ANCHOR BOLT-LSB STYLE UNKNOWN manufactured by Ad-tech Medical Instrument Corp..
[62701497]
According to ad-tech clinical specialist, the anchor bolts most likely broke or bent after implantation. In this specific case (as stated in the event description), the patient experienced a grand mal seizure which resulted in the patient pulling the electrodes out. The majority of the anchor bolt breaks occurred at the threads on the bolts. Because of this, the surgeon had to make a bigger incision during explant. It was mentioned that per protocol at mt. Sinai, all seeg patients are confined to their beds in the icu after surgery and for the duration of recording. Padding is used around the bed for safety protocol. This investigation is currently still ongoing.
Patient Sequence No: 1, Text Type: N, H10
[62701498]
Ad-tech was made aware of an issue on (b)(6) 2016 in regards to the use of their cranial anchor bolts. The customer reported that they experienced several anchor bolts that either broke or bent during the course of the surgery process, resulting in more invasive explant incisions. It was stated that the customer noticed the bolts broke or bent after implant, during post-operative monitoring. Further information was received on (b)(6) 2016. It was found that the patient had 13 cranial anchor bolts implanted and all 13 anchor bolts broke. The patient experienced a grand mal seizure during post-operative monitoring which resulted in the patient pulling the electrodes out. Majority of the anchor bolt breaks occurred at the threads on the bolts. Because of this, the surgeon had to make a bigger incision during explant. To date, there have been no reports in regards to negative impact to patient safety.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183456-2016-00008 |
| MDR Report Key | 6181674 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-12-16 |
| Date of Report | 2016-12-16 |
| Date Mfgr Received | 2016-11-17 |
| Date Added to Maude | 2016-12-16 |
| 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 | 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 | 2016-12-16 |
| Catalog Number | UNKNOWN |
| 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 | 2016-12-16 |