BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 7376577 · Received March 28, 2018

    Report

    Report Number
    1030489-2018-00460
    Event Type
    Injury
    Date Received
    March 28, 2018
    Report Date
    March 28, 2018
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. D4: THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY: PRODUCT ID: 876-314, QTY: 4, 510K: K970806, UDI: (B)(4). PRODUCT ID: 876-014, QTY: 2, 510K: K970806, UDI: (B)(4). PRODUCT ID: 976-142, QTY: 1, 510K: K021461, UDI: (B)(4). ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PROCEDURE: EXTRAPHARYNGEAL ANTEROLATERAL LEVELS IMPLANTED: C4-C5 AND C5-C6 IT WAS REPORTED VIA A CLINICAL STUDAY THAT THE PATIENT WAS SEEN ON (B)(6) 2017 FOR THEIR 120-MONTH POSTOPERATIVE VISIT FOR THE STUDY AND REPORTED THE FOLLOWING: APPROXIMATELY 104 MONTHS POSTOPERATIVELY, THE PATIENT HAD WORSENING NECK PAIN REQUIRING SURGICAL TREATMENT. SHE EXPERIENCED WEAKNESS IN ARMS AND HANDS, AND WAS SUBSEQUENTLY DIAGNOSED WITH CERVICAL RADICULOPATHY, CERVICAL SPONDYLOSIS, AND KYPHOSIS OF CERVICAL REGION. TREATMENT INCLUDED SELECTIVE NERVE ROOT BLOCKS AT C2-C3, C5-C6, MEDICATIONS AND A CERVICAL MRI THAT SHOWED STENOSIS AT C3-C4, LEFT GREATER THAN RIGHT. APPROXIMATELY 110 MONTHS POSTOPERATIVELY, THE PATIENT UNDERWENT C3-C5 POSTERIOR FUSION WITH INSTRUMENTATION C3-C4 AND FORAMINOTOMIES BILATERALLY C3-C4, LEFT SIDE C4-C5. HOSPITALIZATION WAS NOT REQUIRED. AT THE 120-MONTH POSTOPERATIVE STUDY VISIT, THE PATIENT CONTINUED TO HAVE NECK PAIN AND WEAKNESS IN ARMS AND HANDS. ON (B)(6) 2016: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSISED WITH CERVICAL RADICULOPATHY, SPONDYLYSIS, KYPHOSIS OF CERVICAL REGION AND FAILED BAC SURGERY SYNDROME AND UNDERWENT THE FOLLOWING PROCEDURES: POSTERIOR CERVICAL ARTHRODESIS C3 TO C5, POSTERIOR CERVICAL INSTRUMENTATION AT C3-C4, POSTERIOR CERVICAL FORAMINOTOMIES BILATERALLY C3-4 AND LEFT SIDE C4-5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220515 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other| R