BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 8987431 · Received September 11, 2019

    Report

    Report Number
    1030489-2019-01002
    Event Type
    Injury
    Date Received
    September 11, 2019
    Report Date
    September 11, 2019
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER: SUPERFICIAL INFECTION, WOUND NECROSIS, INCREASE IN SYMPTOMS, DEEP INFECTION. THE FOLLOWING PRODUCTS HAVE BEEN USED IN THE SURGERY: PART# 75446545; 510K# K042025; UDI# (B)(4); QTY# 11 PART# 75446550; 510K# K042025; UDI# (B)(4); QTY# 13 PART# 75446555; 510K# K042025; UDI# (B)(4); QTY# 2 PART# 75447540; 510K# K042025; UDI# (B)(4); QTY# 3 PART# 75447545; 510K# K042025; UDI# (B)(4); QTY# 11 PART# 75447550; 510K# K042025; UDI# (B)(4); QTY# 12 PART# 75446540; 510K# K042025; UDI# (B)(4); QTY# 4 PART# 869-011; 510K# K031655; UDI# (B)(4); QTY# 2 PART# 75447555; 510K# K042025; UDI# (B)(4); QTY# 3 ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA POST-OPERATIVE CLINICAL STUDY (WITH MINIMUM 12 MONTHS FOLLOW-UP) INVOLVING 155 PATIENTS WITH SPONDYLOLISTHESIS (103 PATIENTS), DEGENERATIVE DISC DISEASE (29 PATIENTS), STENOSIS (15 PATIENTS), RETROLISTHESIS (2 PATIENTS), DEGENERATION OF FACETS (3 PATIENTS) AND 3 DIAGNOSED WITH SPONDYLOLYSIS. POST-OP, 9 PATIENTS SUFFERED FROM SUPERFICIAL INFECTION, INCREASE IN SYMPTOMS IN 4 PATIENTS WAS OBSERVED, AND 1 PATIENT HAD WOUND NECROSIS. 6 PATIENTS SUFFERED FROM DEEP INFECTION OUT OF WHICH 2 PATIENTS DIED DUE TO COMPLICATIONS RESULTING FROM DEEP WOUND INFECTIONS. A TOTAL OF 7 PATIENTS UNDERWENT RE-SURGERY DUE TO THE ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784878 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other| R