MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-04-02 for ANCHOR BOLTS LSBK1-AX-06 manufactured by Ad-tech Medical Instrument Corp..
[146915170]
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 13 similar complaints for anchor bolts breaking between january 1, 2017 and march 18, 2019. A capa and investigation review was also conducted for the alleged deficiency "anchor bolt broke during implantation" and there have been no capas or investigations opened for this issue to date. A batch record review was conducted; (b)(4) lsbk1-ax-06 anchor bolts were planned for this work order and (b)(4) were completed. No issues were noted in the work order process notes that would contribute to the reported complaint. All (b)(4) lsbk1-ax-06 anchor bolts passed the in-process and final qc checks. No product return analysis could be performed for this complaint as no product was returned. According to the customer's sales representative, the patient's skull was thicker and required more force to place the bolt. The neurosurgeon was more aggressive when attempting to insert (i. E. , screw in) this bolt into the skull; thus resulting in the bolt snapping. The risk level for this issue remains alap (as low as possible). Additionally, based on a review of previous complaints for anchor bolt breakages and an analysis of all anchor bolt breakage complaint data, the current rate of anchor bolt breakage complaints versus products sold is very low; (b)(4) over the past 2 years. Ad-tech is continuing to monitor this issue closely.
Patient Sequence No: 1, Text Type: N, H10
[146915171]
On march 15, 2019, ad-tech received a copy of a medwatch 3500a report from the food and drug administration (fda). The report was from a user facility (uf), documented under uf report # (b)(4). According to the form, it was stated that, "... When inserting the anchor bolt, the bolt snapped... " part of the bolt remained in the skull and a needle driver was used to secure the anchor bolt, thus enabling the bolt to be unscrewed for removal. According to the user facility, they were not aware of any other information about the patient that may have influenced the outcome of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183456-2019-00001 |
| MDR Report Key | 8472930 |
| Report Source | USER FACILITY |
| Date Received | 2019-04-02 |
| Date of Report | 2019-03-25 |
| Date Facility Aware | 2019-02-01 |
| Report Date | 2019-03-15 |
| Date Reported to Mfgr | 2019-03-15 |
| Date Mfgr Received | 2019-03-15 |
| Device Manufacturer Date | 2018-06-11 |
| Date Added to Maude | 2019-04-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 WI 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 WI 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 BOLTS |
| Generic Name | ANCHOR BOLT (ACCESSORY TO DEPTH ELECTRODES) |
| Product Code | GZL |
| Date Received | 2019-04-02 |
| Catalog Number | LSBK1-AX-06 |
| Lot Number | 208140678/0121088 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DA |
| 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 | 2019-04-02 |