MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORP. ANCHOR BOLT, LSB STYLE

Catalog Number LSBK2-BX-04

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/15/2018

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: ANCHOR BOLT, LSB STYLE
• Type of Device: ANCHOR BOLT, LSB STYLE
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek, wi
• Manufacturer (Section G): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek, wi
• Manufacturer Contact: pamela stogsdill ; 400 west oakview parkway; oak creek, wi ; 6341555301
• MDR Report Key: 9734954
• MDR Text Key: 186565235
• Report Number: 2183456-2019-00019
• Device Sequence Number: 1
• Product Code: GZL
• UDI-Device Identifier: 00841823104342
• UDI-Public: (01)00841823104342(17)200101(10)0117458208140664
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K181544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2020
• Device Catalogue Number: LSBK2-BX-04
• Device Lot Number: 208140664
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 02/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1