BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR BOLT-LSB STYLE

    MDR report key: 6181674 · Received December 16, 2016

    Report

    Report Number
    2183456-2016-00008
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Report Date
    December 16, 2016
    Manufacturer
    AD-TECH MEDICAL INSTRUMENT CORP.
    Product Code
    GCZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AD-TECH CLINICAL SPECIALIST, THE ANCHOR BOLTS MOST LIKELY BROKE OR BENT AFTER IMPLANTATION. IN THIS SPECIFIC CASE (AS STATED IN THE EVENT DESCRIPTION), THE PATIENT EXPERIENCED A GRAND MAL SEIZURE WHICH RESULTED IN THE PATIENT PULLING THE ELECTRODES OUT. THE MAJORITY OF THE ANCHOR BOLT BREAKS OCCURRED AT THE THREADS ON THE BOLTS. BECAUSE OF THIS, THE SURGEON HAD TO MAKE A BIGGER INCISION DURING EXPLANT. IT WAS MENTIONED THAT PER PROTOCOL AT MT. SINAI, ALL SEEG PATIENTS ARE CONFINED TO THEIR BEDS IN THE ICU AFTER SURGERY AND FOR THE DURATION OF RECORDING. PADDING IS USED AROUND THE BED FOR SAFETY PROTOCOL. THIS INVESTIGATION IS CURRENTLY STILL ONGOING.

    Description of Event or Problem · 1

    AD-TECH WAS MADE AWARE OF AN ISSUE ON (B)(6) 2016 IN REGARDS TO THE USE OF THEIR CRANIAL ANCHOR BOLTS. THE CUSTOMER REPORTED THAT THEY EXPERIENCED SEVERAL ANCHOR BOLTS THAT EITHER BROKE OR BENT DURING THE COURSE OF THE SURGERY PROCESS, RESULTING IN MORE INVASIVE EXPLANT INCISIONS. IT WAS STATED THAT THE CUSTOMER NOTICED THE BOLTS BROKE OR BENT AFTER IMPLANT, DURING POST-OPERATIVE MONITORING. FURTHER INFORMATION WAS RECEIVED ON (B)(6) 2016. IT WAS FOUND THAT THE PATIENT HAD 13 CRANIAL ANCHOR BOLTS IMPLANTED AND ALL 13 ANCHOR BOLTS BROKE. THE PATIENT EXPERIENCED A GRAND MAL SEIZURE DURING POST-OPERATIVE MONITORING WHICH RESULTED IN THE PATIENT PULLING THE ELECTRODES OUT. MAJORITY OF THE ANCHOR BOLT BREAKS OCCURRED AT THE THREADS ON THE BOLTS. BECAUSE OF THIS, THE SURGEON HAD TO MAKE A BIGGER INCISION DURING EXPLANT. TO DATE, THERE HAVE BEEN NO REPORTS IN REGARDS TO NEGATIVE IMPACT TO PATIENT SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831810 ANCHOR BOLT-LSB STYLE ANCHOR BOLT-LSB STYLE GCZ AD-TECH MEDICAL INSTRUMENT CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other