BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-FACTOR

    MDR report key: 18952823 · Received March 21, 2024

    Report

    Report Number
    3007155473-2024-20075
    Event Type
    Injury
    Date Received
    March 21, 2024
    Report Date
    March 21, 2024
    Manufacturer
    CERAPEDICS
    Product Code
    MBS
    PMA / PMN Number
    P140019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT-SPECIFIC INFORMATION WAS NOT PROVIDED BY THE COMPLAINANT. ALL PRODUCTS MANUFACTURED ARE SUBJECT TO A RIGOROUS DHR REVIEW THROUGHOUT THE PROCESS AND AS PART OF RELEASE TO FINISHED GOODS. WHILE THE PRODUCT LOT NUMBER IS NOT KNOWN FOR THIS PATIENT/CASE, THERE IS NO INDICATION THAT ANY PRODUCT DISTRIBUTED FAILED TO MEET SPECIFICAITONS. BASED ON THE INFORMATION GATHERED, NO CAUSAL LINK COULD BE ESTABLISHED BETWEEN I-FACTOR FLEX FR AND THE REPORTED COMPLAINT. OTHER POTENTIAL CONTRIBUTING FACTORS TO CONSIDER ARE THE PATIENT PHYSIOLOGY/CONDITION AND/OR CONCOMITANT DEVICES USED FOR THE SURGERY.

    Description of Event or Problem · 0

    1 POSTERIOR NECK LEADING TO CORD COMPRESSION AND SPINAL CORD INJURY - GWJ PATIENT. THE FOLLOWING SUMMARY PROVIDES ADDITIONAL INFORMATION GAINED DURING A MARCH 11TH DISCUSSION HELD BETWEEN (B)(6) AND SURGEON: AGE OF PATIENT IS UNKNOWN. SURGERY WAS PERFORMED IN (B)(6) 2019. I-FACTOR FLEX FR WAS USED AS A STANDALONE GRAFT IN THE POSTERIOR CERVICAL SPINE FOLLOWING LAMINECTOMY. SWELLING IN POSTERIOR SPINE MEANT THAT THERE WAS COMPRESSION DIRECTLY ONTO THE SPINAL CORD RESULTING IN LOSS OF RESPIRATORY FUNCTION. THIS OCCURRED WITHIN 24 HOURS OF THE OPERATION. THE PATIENT WAS TAKEN BACK TO THEATRE AS AN EMERGENCY CASE TO HAVE THE SWELLING REMOVED. SEROMA WAS DRAINED AND PRESSURE RELEASED. SEROMA WAS MORE ORANGE IN COLOUR - SURGEON DID NOT KNOW WHY WHEN ASKED AGAIN REGARDING THIS OBSERVATION. HE WOULD EXPECT THE MATERIALS TO BE CLEAR, STRAW COLOUR .NO OTHER FACTORS WHICH MAY HAVE CONTRIBUTED TOT HE SEROMA FORMATION. SURGEON CONFIRMED THAT THERE WAS NO RADIOLOGICAL EVIDENCE OF I-FACTOR MIGRATION. HE SUGGESTED THE ONLY CHANGE WAS THE INTRODUCTION OF I-FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524425 I-FACTOR FILLER, BONE VOID, NON-OSTEOINDUCTION MBS CERAPEDICS UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other MEDTRONIC POSTERIOR RODS AND SCREWS