BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSTONE SPINAL SYSTEM

    MDR report key: 9390987 · Received November 29, 2019

    Report

    Report Number
    1030489-2019-01355
    Event Type
    Injury
    Date Received
    November 29, 2019
    Report Date
    November 29, 2019
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    MAX
    UDI-DI
    00613994291042
    PMA / PMN Number
    K073291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY: PART#2991222; LOT# H12L3562; 510K# K073291; UDI# (B)(4); QUANTITY: 1 PART#2991222; LOT# H11L2776; 510K# K073291; UDI# (B)(4); QUANTITY: 1 PART#2991222; LOT# H11L2776; 510K# H12G0824; UDI# (B)(4); QUANTITY:1 PART#G75446540; LOT# H12J1114; QUANTITY: 2 PART#G75446540; LOT# H12F3164; QUANTITY: 3 PART#G75446540; LOT# H11L3058; QUANTITY: 2 PART#G84193HT; LOT# 0215210W; QUANTITY: 1 PART#G869H021; LOT# 0224701W; QUANTITY:1 ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, 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 THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION AT L5/S.POST OPERATIVELY , AFTER THE FIXATION AT TH11-L5, SPONDYLOLISTHESIS OCCURRED AT L5/S AND THERE WAS LOWER EXTREMITY SYMPTOM.. THE PATIENT SUFFERED FROM DISABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1185890 CAPSTONE SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MDT SOFAMOR DANEK PUERTO RICO MFG NA H12L3562 00613994291042

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability