MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-04-27 for ANCHOR BOLT-LSB STYLE LSBK1-AX-05 manufactured by Ad-tech Medical Instrument Corp..
[106871665]
As stated in the event description section, ad-tech responded back to the customer the day they were notified to obtain additional information. To date, the customer has not responded back. Thus, it is unknown what the outcome/current status is of the patient. 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 ten similar complaints for anchor bolts breaking between 1/1/2016 and 3/29/2018. A capa and investigation 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 4/6/2018 (for lot 208140625, batch# 103573). Specific to batch# 103573, (b)(4) (lsbk1) anchor bolts were planned for this work order and (b)(4) 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. The products were returned to ad-tech on 4/13/2018 and a return analysis was completed. Specific to this complaint, three lsbk1-ax-05 (21mm) and three lsbk1-bx-05 (13 mm) anchor bolts were returned. The products were received in a used and unsterilized condition. A visual examination was able to be performed through the clear packaging in which products were received. Four of the six anchor bolts were returned unbroken: one lsbk1-ax-05 (21mm), and three lsbk1-bx-05 (13mm). The other two anchor bolts lsbk1-ax-05 (21mm) were visually confirmed to be broken at the thread area that would affix the anchor bolt to the skull of a patient. Therefore, the complaint return analysis does confirm the reported alleged deficiency. A risk assessment was performed and the risk level is considered alap (as low as possible). The investigation is still on-going as ad-tech is awaiting further information from the distributor/customer.
Patient Sequence No: 1, Text Type: N, H10
[106871666]
On 3/29/2018, the ad-tech clinical specialist received an email from a distributor stating that they were informed by one of their customers that during a case, two ad-tech anchor bolts "fell off" a few days after implantation. A ct scan was performed and the "distal screw part" of the anchor bolts remained in the patient, which showed that the anchor bolts were snapped after implantation. A second surgery was scheduled to remove all the electrodes with anchor bolts on (b)(6) 2018. The distributor stated that the patient was experiencing a fever and the hospital did not know if this was due to the open wound from the broken anchor bolts or other clinical reasons. Ad-tech responded back to the customer the day they were notified to obtain additional information to help aid with the complaint investigation. To date, the customer has not responded back. It is unknown what the outcome or current status is of the patient. A supplement report will be initiated should ad-tech receive additional information relevant to this medwatch report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183456-2018-00002 |
| MDR Report Key | 7469504 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-04-27 |
| Date of Report | 2018-09-21 |
| Date of Event | 2018-03-19 |
| Date Mfgr Received | 2018-03-29 |
| Device Manufacturer Date | 2016-10-12 |
| Date Added to Maude | 2018-04-27 |
| 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 OAKVIEW PARKWAY |
| Manufacturer City | OAK CREEK 53154 |
| Manufacturer Country | US |
| Manufacturer Postal | 53154 |
| 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 | 2018-04-27 |
| Returned To Mfg | 2018-04-13 |
| Catalog Number | LSBK1-AX-05 |
| Lot Number | 208140625 |
| Device Expiration Date | 2018-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-04-27 |