MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-08-29 for ANCHOR BOLT - LSB STYLE N/A LSBK2-AX-04 manufactured by Ad-tech Medical Instrument Corp..
[118883107]
As stated in the event description section, on (b)(6) 2018, the ad-tech clinical specialist received a phone call from a customer stating that an anchor bolt sheered at the distal tip and transected the electrode. The anchor bolt had been placed in the occipital area. According to the doctor, the patient had no ill effects from the anchor bolt breakage. An internal complaint investigation was performed for this issue. Specifically, a historical complaints review was completed for the alleged deficiency, "broken anchor bolts". There have been 12 similar complaints for anchor bolts breaking between january 1, 2016 and (b)(6) 2018. A capa and investigations review was also conducted for the alleged deficiency "anchor bolt broke after implantation" and there have been no capas or investigations opened for this issue to date. A batch record review was performed for the impacted product on august 16, 2018 (for lot 208140671, batch# 119824). Specific to batch# 119824, 50 (lsbk2-ax-04) anchor bolts were planned for this work order and 50 were completed. There were no additional issues noted in the work order process notes that would contribute to the reported complaint and all kits passed the in-process and final qc checks. No complaint return analysis could be performed as the product was not returned to ad-tech. On august 14, 2018 ad-tech's complaints manager and compliance specialist spoke with the clinical specialist that was at the case in regards to the broken bolt issue that was seen in the complaint. According to the clinical specialist, he stated that the doctor contacted him via phone 6 days after the surgery to let him know that the lsbk2-ax-04 anchor bolt sheered at the distal tip (approximately 3 mm at the tip) and transected the electrode. The patient had a seizure which resulted in the bolt breaking. When asked about the case, the clinical specialist stated that he was there when the surgery occurred, but was not present when the bolt broke a couple days later. During the surgery, the doctor had inquired about wanting a larger recording area. The specialist had suggested using an rd depth electrode instead of the sd depth electrode that this doctor typically uses. The doctor had 1 rd electrode readily available, but no associated anchor bolt. The specialist checked his bag and found 1 lsbk2-ax-04 anchor bolt that he had on hand. He mentioned it was a longer bolt (21 mm), but could still be used. He also stated that the bolt had good purchase when placed in the skull. He did however caution the doctor that it is possible that the bolt could potentially break based on where it was positioned (on the back side of the skull and sticking out quite a bit). The doctor then packed the area of the bolt with multiple layers of gauze foam to protect the integrity of the bolt and electrode. Based on this information, the root cause is that the anchor bolt broke as a result of the seizure that the patient experienced. Per the risk assessment, the risk level remains alap (as low as possible). All anchor bolt products were evaluated to obtain the mean annual clinical uses. All complaints identified through the historical complaint review were considered during occurrence calculations, since none refuted the reported deficiency. The occurrence value matches the occurrence level present within ad-tech's user failure modes and effects analysis (ufmea) for anchor bolts. As stated in ad-tech's benefit versus risk documentation, all indicated uses of the device have mitigated risks that are determined to be alap. In view of the complete analysis, the benefits outweigh the risks. No further risk mitigations are available thus no corrective actions will be implemented as part of the complaint. The device malfunction did not cause a death or serious injury nor would it cause a death or serious injury should it recur. The broken bolt was able to be removed without causing injury.
Patient Sequence No: 1, Text Type: N, H10
[118883108]
On (b)(6) 2018, the ad-tech clinical specialist received a phone call from a customer stating that an anchor bolt sheered at the distal tip and transected the electrode. The anchor bolt had been placed in the occipital area. According to the doctor, the patient had no ill effects from the anchor bolt breakage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183456-2018-00005 |
| MDR Report Key | 7828308 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-08-29 |
| Date of Report | 2018-08-23 |
| Date of Event | 2018-07-31 |
| Date Mfgr Received | 2018-08-06 |
| Device Manufacturer Date | 2018-04-12 |
| Date Added to Maude | 2018-08-29 |
| 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 | MRS. KATHLEEN BARLOW |
| Manufacturer Street | 400 WEST OAKVIEW PARKWAY |
| Manufacturer City | OAK CREEK 53154 |
| Manufacturer Country | US |
| Manufacturer Postal | 53154 |
| Manufacturer Phone | 2626341555 |
| Manufacturer G1 | AD-TECH MEDICAL INSTRUMENT CORP. |
| Manufacturer Street | 400 WEST OAKVIEW PARKWAY |
| Manufacturer City | OAK CREEK 53154 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53154 |
| 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 | 2018-08-29 |
| Model Number | N/A |
| Catalog Number | LSBK2-AX-04 |
| Lot Number | 208140671 |
| 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 CORP. |
| Manufacturer Address | 400 WEST OAKVIEW PARKWAY OAK CREEK 53154 US 53154 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-29 |