MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-02-20 for ANCHOR BOLT, LSB STYLE LSBK2-BX-04 manufactured by Ad-tech Medical Instrument Corp..
[186565235]
Mdr 2183456-2019-00019 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 occured, 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.
Patient Sequence No: 1, Text Type: N, H10
[186565236]
On (b)(6) 2018 ad-tech received an email from a distributor about an issue their customer experienced in a case using ad-tech anchor bolts. Specifically, "we had seeg case on last saturday, surgeon just noticed that cfs leaked from anchor bolt as attachment. " further correspondence indicated that the surgeon noticed the csf (cerebral spinal fluid) leakage after he placed the silicone cap on the anchor bolt. The leakage was coming from the gap between the electrode and the top of the cap, after the silicone cap was secured on anchor bolt cap. It was then stated that after the patient was transferred to the ward, it seemed that the csf stopped leaking and everything seemed to be ok.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183456-2019-00019 |
| MDR Report Key | 9734954 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-20 |
| Date of Event | 2018-12-15 |
| Date Mfgr Received | 2018-12-20 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. PAMELA STOGSDILL |
| 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 |
| 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 | GZL |
| Date Received | 2020-02-20 |
| Catalog Number | LSBK2-BX-04 |
| Lot Number | 208140664 |
| Device Expiration Date | 2020-01-01 |
| 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 |