BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCLERAL BUCKLING PRODUCTS: STYLE 70, SILICONE SLEEVE

    MDR report key: 16069258 · Received December 29, 2022

    Report

    Report Number
    1222074-2022-00089
    Event Type
    Malfunction
    Date Received
    December 29, 2022
    Date of Event
    September 15, 2022
    Report Date
    February 14, 2023
    Manufacturer
    D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.
    Product Code
    HQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    WE HAVE BEEN INFORMED THROUGH MEDWATCH REPORT MW5112600, THAT ON (B)(6) 2022 THE PATIENT HAD SURGERY ON THE LEFT EYE FOR A DETACHED RETINA. IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AND HAD BEEN HOSPITALIZED AT ANOTHER HEALTH SYSTEM AND UNDERWENT IMPLANT REMOVAL PER (B)(6) 2022. OPERATIVE NOTE, SCLERAL BUCKLE BAND 42, REF (B)(4), LOT NO. 2404100 WAS PASSED 360 DEGREES UNDER EACH OF RECTUS MUSCLES AND SECURED IN THE SUPRANASAL QUADRANT USING A 70 SLEEVE, REF (B)(4), LOT NO. 2407107. ALL THE BUCKLE ELEMENTS WERE SECURED IN EACH QUADRANT USING 5.0 MERCILINE SUTURE. THE SURGEON SHARED THAT THE CULTURE HAD GROWN STAPH AUREUS ORGANISM. SINCE THE INVOLVED PRODUCT WAS NOT RETURNED, NO PHYSICAL EXAMINATION WAS PERFORMED. PERTINENT TO THE REPORTED INFECTION, THE STERILIZATION RECORDS RELATED TO THE LOT WERE REVIEWED. THE STERILIZATION PROCESS WAS COMPLETED SUCCESSFULLY AND THE LOAD WAS DECLARED TO BE STERILE. HENCE, THE STAPHYLOCOCCUS AUREUS INFECTION CANNOT BE ATTRIBUTED TO THE SCLERAL BUCKLING PRODUCT FROM DORC. PLEASE NOTE THAT, AS WITH ALL SURGICAL IMPLANTS, THERE IS A POSSIBILITY OF ADVERSE REACTIONS IN THE HUMAN BODY. LONG-TERM CLINICAL EXPERIENCE WITH USE OF SCLERAL BUCKLING PRODUCTS HAS SHOWN THAT THE RISK OF SUCH REACTIONS IS LOW AND THAT ADVANTAGES CLEARLY OUTWEIGH ANY RISK FACTOR. AS WITH ALL SCLERAL BUCKLING PRODUCTS, THE POSSIBILITY OF EXTRUSION, EROSION OR INADVERTENT INFECTION EXISTS. A REFERENCE TO POSSIBLE ADVERSE REACTIONS IS STATED IN THE INSTRUCTION FOR USE THAT WERE PROVIDED WITH THE PRODUCT. THE RISK IDENTIFIED IS INCLUDED IN THE RISK MANAGEMENT DOCUMENTATION. TREND ANALYSIS INDICATES THAT THE PRODUCT IS PERFORMING WITHIN ANTICIPATED RATES. COMPLAINTS WILL BE CLOSELY MONITORED TO IDENTIFY ANY SIGNIFICANT ADVERSE TRENDS.SINCE THE REPORTED ADVERSE EVENT CANNOT BE ATTRIBUTED TO THE DORC PRODUCT, NO REMEDIAL ACTION/CORRECTIVE ACTION/PREVENTIVE ACTION/FIELD SAFETY CORRECTIVE ACTION (FSCA) WILL BE TAKEN.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS UNDER INVESTIGATION. NO CORRECTIVE OR PREVENTIVE ACTIONS CAN BE IMPLEMENTED UNTIL THE INVESTIGATION HAS BEEN COMPLETED. IN CASE OF A PRODUCT RETURN, THE DEVICE WILL BE INVESTIGATED, OTHERWISE WE WILL REVIEW THE DEVICE HISTORY RECORD, AND/OR ANY LOG FILES IF AVAILABLE.

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED THROUGH MEDWATCH REPORT MW5112600, THAT ON (B)(6) 2022 THE PATIENT HAD SURGERY ON THE LEFT EYE FOR A DETACHED RETINA. IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AND HAD BEEN HOSPITALIZED AT ANOTHER HEALTH SYSTEM AND UNDERWENT IMPLANT REMOVAL PER (B)(6) 2022. OPERATIVE NOTE, SCLERAL BUCKLE BAND 42, REF (B)(4), LOT NO. 2404100 WAS PASSED 360 DEGREES UNDER EACH OF RECTUS MUSCLES AND SECURED IN THE SUPRANASAL QUADRANT USING A 70 SLEEVE, REF (B)(4), LOT NO. 2407107. ALL THE BUCKLE ELEMENTS WERE SECURED IN EACH QUADRANT USING 5.0 MERCILINE SUTURE. THE SURGEON SHARED THAT THE CULTURE HAD GROWN STAPH AUREUS ORGANISM.

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED THROUGH MEDWATCH REPORT MW5112600, THAT ON (B)(6) 2022 THE PATIENT HAD SURGERY ON THE LEFT EYE FOR A DETACHED RETINA. IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AND HAD BEEN HOSPITALIZED AT ANOTHER HEALTH SYSTEM AND UNDERWENT IMPLANT REMOVAL PER (B)(6) 2022. OPERATIVE NOTE, SCLERAL BUCKLE BAND 42, REF (B)(4) , LOT NO. 2404100 WAS PASSED 360 DEGREES UNDER EACH OF RECTUS MUSCLES AND SECURED IN THE SUPRANASAL QUADRANT USING A 70 SLEEVE, REF (B)(4), LOT NO. 2407107. ALL THE BUCKLE ELEMENTS WERE SECURED IN EACH QUADRANT USING 5.0 MERCILINE SUTURE. THE SURGEON SHARED THAT THE CULTURE HAD GROWN STAPH AUREUS ORGANISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454506 SCLERAL BUCKLING PRODUCTS: STYLE 70, SILICONE SLEEVE RETINAL DETACHMENT IMPLANT HQX D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. 2404100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown