MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-09-13 for ANCHOR BOLT - LSB STYLE LSBK1-AX-05 manufactured by Ad-tech Medical Instrument Corp..
[120702863]
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 thirteen similar complaints for anchor bolts breaking between january 1, 2016 and august 14, 2018. A capa and investigation review was also conducted for the alleged deficiency "anchor bolts (2) broke-1 during & 1 after implantation" and there have been no capas or investigations opened for this issue to date. A batch record review was conducted; 50 lsbk1-ax-05 anchor bolts were planned for this work order and 50 were completed. No issues were noted in the work order process notes that would contribute to the reported complaint. The 50 lsbk1-ax-05 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. 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
[120702864]
On august 14, 2018 ad-tech's clinical specialist received a phone call from a customer stating that 2 anchor bolts had sheared off at the threads. One bolt had sheared off while being screwed into the skull during implantation and the neurosurgeon drilled out the threaded portion. The second sheared bolt was found 6 days post-op. The threads still remain in the skull and will be drilled out during ex-plantation. To date, it is unknown what the current status is of the patient. It was stated that specific to the sheared bolt seen during implantation, the trajectory was scrapped and re-planned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183456-2018-00006 |
| MDR Report Key | 7873064 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-09-13 |
| Date of Report | 2018-09-13 |
| Date of Event | 2018-08-08 |
| Date Mfgr Received | 2018-08-14 |
| Device Manufacturer Date | 2018-06-14 |
| Date Added to Maude | 2018-09-13 |
| 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 | 2018-09-13 |
| Catalog Number | LSBK1-AX-05 |
| Lot Number | 208140678 |
| Device Expiration Date | 2018-06-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2018-09-13 |