ANCHOR BOLT, LSB STYLE LSBK2-BX-04

MAUDE Adverse Event Report

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..

Event Text Entries

[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


MAUDE Entry Details

Report Number2183456-2019-00019
MDR Report Key9734954
Report SourceDISTRIBUTOR,FOREIGN
Date Received2020-02-20
Date of Report2020-02-20
Date of Event2018-12-15
Date Mfgr Received2018-12-20
Date Added to Maude2020-02-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. PAMELA STOGSDILL
Manufacturer Street400 WEST OAKVIEW PARKWAY
Manufacturer CityOAK CREEK, WI
Manufacturer CountryUS
Manufacturer Phone6341555301
Manufacturer G1AD-TECH MEDICAL INSTRUMENT CORP.
Manufacturer Street400 WEST OAKVIEW PARKWAY
Manufacturer CityOAK CREEK, WI
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameANCHOR BOLT, LSB STYLE
Generic NameANCHOR BOLT, LSB STYLE
Product CodeGZL
Date Received2020-02-20
Catalog NumberLSBK2-BX-04
Lot Number208140664
Device Expiration Date2020-01-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAD-TECH MEDICAL INSTRUMENT CORP.
Manufacturer Address400 WEST OAKVIEW PARKWAY OAK CREEK, WI US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-20

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