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 UNKNOWN manufactured by Ad-tech Medical Instrument Corporation.
[106961423]
As stated in the event description, the clinical specialist did not have any additional information at this time but followed up on the incident with the (b)(4) representative in (b)(4). A response has not been received to date. 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 while being placed" and there have been no capas or investigations opened for this issue to date. The investigation is still on-going as ad-tech is awaiting further information from the customer.
Patient Sequence No: 1, Text Type: N, H10
[106961424]
On (b)(6) 2018, while attending a case at a customer site, the ad-tech clinical specialist was notified by the (b)(6) representative that during a case at a separate customer site, she witnessed an anchor bolt breaking during placement. Ad-tech reached out to the customer 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 | 2183456-2018-00003 |
| MDR Report Key | 7470438 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-04-27 |
| Date of Report | 2018-09-21 |
| Date Mfgr Received | 2018-03-28 |
| 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 | MS. 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 CORPORATION |
| 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 BOLT-LSB STYLE |
| Generic Name | ANCHOR BOLT-LSB STYLE |
| Product Code | GCZ |
| Date Received | 2018-04-27 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| 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 CORPORATION |
| Manufacturer Address | 400 WEST OAKVIEW PARKWAY OAK CREEK WI 53154 US 53154 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-27 |