BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIVOX OBLIQUE LATERAL SPINAL SYSTEM

    MDR report key: 7322876 · Received March 8, 2018

    Report

    Report Number
    1030489-2018-00340
    Event Type
    Injury
    Date Received
    March 8, 2018
    Report Date
    April 16, 2018
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWQ
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: X-RAY IMAGE REVIEW: PRE-OP AND POST-OP X-RAYS FOR L3-4, L4-5 OLIF. THE INITIAL CONSTRUCT WAS INTERBODY ONLY AND THERE WAS A FRACTURE OF THE L4 VERTEBRAL BODY POST-OP. THIS MAY BE CAUSED BY SCREW-SCREW INTERACTION WITH IN THE BODY BEFORE FUSION OCCUR. THE DEVICE IS INDICATED FOR USE IN ONE OR TWO CONTINUOUS LEVELS. I DO NOT SEE THE FRACTURE ON PROVIDED IMAGING AND HARDWARE PLACEMENT APPEARS APPROPRIATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. CATALOG NO.:2140145; LOT NO.: 0527103W; UDI: (B)(4); 510(K) NO:K152277; QTY: 2. CATALOG NO.:2140145; LOT NO.: 0472687W; UDI: (B)(4); 510(K) NO:K152277; QTY: 2. CATALOG NO.:2140002; LOT NO.: 0474047W; UDI: (B)(4); 510(K) NO:K152277; QTY: 1. CATALOG NO.:2140001; LOT NO.: 0583563W; UDI: (B)(4); 510(K) NO:K152277; QTY: 1. CATALOG NO.:2111455; LOT NO.: H5230582; UDI: (B)(4); 510(K) NO:K152277; QTY: 1. CATALOG NO.:2111355; LOT NO.: H5304053; UDI: (B)(4); 510(K) NO:K152277; QTY: 1. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF 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 PRESENTED WITH L3-L5 DEGENERATIVE DISC DISEASE UNDERWENT OBLIQUE LUMBER INTER BODY FUSION. ON AN UNKNOWN DATE, POST-OP, THE PATIENT HAD L4 VERTEBRAE BODY FRACTURE AND INSTABILITY. THE ADDITIONAL SURGERY WAS PERFORMED WITH POSTERIOR INSTRUMENTATION AND FIXED FEW MONTHS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169010 PIVOX OBLIQUE LATERAL SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention