BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 12089206 · Received June 29, 2021

    Report

    Report Number
    0009617544-2021-00124
    Event Type
    Injury
    Date Received
    June 29, 2021
    Date of Event
    March 1, 2011
    Report Date
    November 3, 2021
    Manufacturer
    STRYKER SPINE-US
    Product Code
    MQP
    PMA / PMN Number
    K060506
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE ARTICLE 'POSTERIOR APPROACH FOR THORACOLUMBAR CORPECTOMIES WITH EXPANDABLE CAGE PLACEMENT AND CIRCUMFERENTIAL ARTHRODESIS: A MULTICENTER CASE SERIES OF (B)(4) PATIENTS' IN THE JOURNAL OF NEUROSURGERY: SPINE, VOLUME 14 ( 388¿397) 2011, WAS REVIEWED. VISUAL, DIMENSIONAL, MATERIAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE NO DEVICES WERE RETURNED.   DEVICE AND COMPLAINT HISTORY RECORDS REVIEW COULD NOT BE PERFORMED AS A VALID LOT CODE WAS NOT PROVIDED AND COULD NOT BE OBTAINED. THIS COMPLAINT ADDRESSES ONE PATIENT WHO EXPERIENCED OVER DISTRACTION OF THEIR IMPLANT WHICH LED TO IMPLANT FAILURE. FURTHERMORE, THE ARTICLE INDICATES THAT A LIGAMENTOUS INJURY MAY HAVE CONTRIBUTED TO THE FAILURE OF A CIRCUMFERENTIAL CONSTRUCT IN THIS PATIENT WHO SUSTAINED AN L-4 BURST FRACTURE AFTER A 40-FOOT FALL (FIG. 1D¿G). GIVEN THE HIGH ENERGY OF THE TRAUMA, IT IS POSSIBLE THAT A LACK OF LIGAMENTOUS COUNTERFORCE ALLOWED OVER DISTRACTION OF THE EXPANDABLE CAGE IN THE PATIENT. LIMITED INFORMATION REGARDING THE EVENT WAS MADE AVAILABLE TO STRYKER. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED. A DEFINITE ROOT CAUSE CANNOT BE ESTABLISHED. IF ADDITIONAL INFORMATION IS RECEIVED THE INVESTIGATION WILL BE REOPENED AND UPDATED.

    Description of Event or Problem · 0

    THIS RECORD CAPTURES A REVIEW OF 'POSTERIOR APPROACH FOR THORACOLUMBAR CORPECTOMIES WITH EXPANDABLE CAGE PLACEMENT AND CIRCUMFERENTIAL ARTHRODESIS: A MULTICENTER CASE SERIES OF (B)(4) PATIENTS' (J NEUROSURG SPINE 14:388¿397, 2011) FROM THE JOURNAL OF NEUROSURG SPINE. THE PURPOSE OF THIS MULTICENTER TRIAL WAS TO INVESTIGATE THE OUTCOME AND DURABILITY OF A SINGLE-STAGE THORACOLUMBAR CORPECTOMY USING EXPANDABLE CAGES VIA A POSTERIOR APPROACH. THE AUTHORS CONDUCTED A RETROSPECTIVE CHART REVIEW OF (B)(4) CONSECUTIVE PATIENTS WHO UNDERWENT SINGLE STAGE THORACOLUMBAR CORPECTOMIES WITH CIRCUMFERENTIAL RECONSTRUCTION FOR PATHOLOGICAL, TRAUMATIC, AND OSTEOMYELITIC PATHOLOGIES. ALL (B)(4) PATIENTS UNDERWENT THE IMPLANTATION OF EXPANDABLE TITANIUM CAGES; SOME OF WHICH WERE DONE WITH VLIFT CAGES. IT WAS REPORTED THAT ONE PATIENT EXPERIENCED OVER DISTRACTION OF THEIR IMPLANT WHICH LED TO IMPLANT FAILURE. REVISION SURGERY WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    STATUS AND LOCATION OF THE DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    THIS RECORD CAPTURES A REVIEW OF 'POSTERIOR APPROACH FOR THORACOLUMBAR CORPECTOMIES WITH EXPANDABLE CAGE PLACEMENT AND CIRCUMFERENTIAL ARTHRODESIS: A MULTICENTER CASE SERIES OF 67 PATIENTS' (J NEUROSURG SPINE 14:388¿397, 2011) FROM THE JOURNAL OF NEUROSURG SPINE. THE PURPOSE OF THIS MULTICENTER TRIAL WAS TO INVESTIGATE THE OUTCOME AND DURABILITY OF A SINGLE-STAGE THORACOLUMBAR CORPECTOMY USING EXPANDABLE CAGES VIA A POSTERIOR APPROACH. THE AUTHORS CONDUCTED A RETROSPECTIVE CHART REVIEW OF 67 CONSECUTIVE PATIENTS WHO UNDERWENT SINGLE STAGE THORACOLUMBAR CORPECTOMIES WITH CIRCUMFERENTIAL RECONSTRUCTION FOR PATHOLOGICAL, TRAUMATIC, AND OSTEOMYELITIC PATHOLOGIES. ALL 67 PATIENTS UNDERWENT THE IMPLANTATION OF EXPANDABLE TITANIUM CAGES; SOME OF WHICH WERE DONE WITH VLIFT CAGES. IT WAS REPORTED THAT ONE PATIENT EXPERIENCED OVER DISTRACTION OF THEIR IMPLANT WHICH LED TO IMPLANT FAILURE. REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983608 UNKNOWN_SPINE_PRODUCT SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP STRYKER SPINE-US

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention