MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-06-28 for ANCHOR BOLT - LSB STYLE LSBK1-AX-05; LSBK1-BX-05 manufactured by Ad-tech Medical Instrument Corp..
[112710632]
As stated in the event description section, ad-tech responded back to the distributor the day they were notified to obtain additional information. To date, the distributor 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 eleven similar complaints for anchor bolts breaking between (b)(6) 2016 and (b)(6) 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. Neither a batch record review nor a product return analysis could be performed for this complaint as no lot information has been given thus far. 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
[112710633]
On 6/5/2018, the ad-tech clinical specialist received an email from one of their distributors stating that they had received a report of fractured bolts from one of their customers. Ad-tech responded back to the distributor the day they were notified to obtain additional information to help aid with the complaint investigation. To date, the distributor 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 | 2183456-2018-00004 |
| MDR Report Key | 7648251 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-06-28 |
| Date of Report | 2018-09-21 |
| Date of Event | 2018-05-22 |
| Date Mfgr Received | 2018-06-05 |
| Date Added to Maude | 2018-06-28 |
| 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 | 2018-06-28 |
| Catalog Number | LSBK1-AX-05; LSBK1-BX-05 |
| Lot Number | SEE SECTION H10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 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 | 2018-06-28 |