MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-20 for ANCHOR BOLT LSBK2-BX-04 manufactured by Ad-tech Medical Instrument Corp..
[186564812]
Mdr 2183456-2020-00018 has been filed past the 30-day timeframe. Through the 2019 fda inspection, it was identified that while ad-tech was evaluating reportability for actual events in which death or serious injury had occurred, ad-tech had failed to submit events in which a malfunction was reported and could result in a serious injury if the event were to recur. As part of the investigation, a two (2) year retrospective review of complaints was performed to determine which complaints required submission of an mdr. While the out of specification condition associated with this report was identified by the surgeon prior to use, recurrence of this issue could potentially impact patient safety if the burr were to make patient contact and remain in situ following the intended surgical operation.
Patient Sequence No: 1, Text Type: N, H10
[186564813]
On (b)(6) 2018, ad-tech received a complaint from a customer stating that the surgeon identified "fuzz" (burr) in one (1) ad-tech anchor bolt on 5/29/2018. The lot and batch numbers were not specified in the original report and were not provided to ad-tech during follow-up request. No known impact to patient safety as the issue was identified prior to use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183456-2020-00018 |
| MDR Report Key | 9732953 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-19 |
| Date of Event | 2018-05-29 |
| Date Mfgr Received | 2018-05-31 |
| Date Added to Maude | 2020-02-20 |
| 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 | MS. KATHLEEN BARLOW |
| Manufacturer Street | 400 WEST OAKVIEW PARKWAY |
| Manufacturer City | OAK CREEK, WI |
| Manufacturer Country | US |
| Manufacturer Phone | 6341555301 |
| Manufacturer G1 | AD-TECH MEDICAL INSTRUMENT CORP. |
| Manufacturer Street | 400 WEST OAKVIEW PARKWAY |
| Manufacturer City | OAK CREEK, WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANCHOR BOLT |
| Generic Name | ANCHOR BOLT |
| Product Code | GZL |
| Date Received | 2020-02-20 |
| Catalog Number | LSBK2-BX-04 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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, WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-20 |