BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTINCT JAVA SCREW, UNKNOWN SIZE

    MDR report key: 9258258 · Received October 30, 2019

    Report

    Report Number
    3003853072-2019-00103
    Event Type
    Injury
    Date Received
    October 30, 2019
    Report Date
    October 2, 2020
    Manufacturer
    ZIMMER SPINE
    Product Code
    MNH
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6 (RESULTS AND CONCLUSION). NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. DEVICE IS USED FOR TREATMENT. INSUFFICIENT INFORMATION PROVIDED. UNABLE TO PERFORM A COMPATIBILITY CHECK. COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. A COMPLAINT HISTORY SEARCH WAS PERFORMED FOR ITEM NUMBER 046W0AN00002 AND DATE GREATER THAN 12 MONTHS PRIOR TO NOTIFICATION DATE, UTILIZING VIEW 20. REGULATORY AFFAIRS ¿ AUDITS/ AUDITOR¿S VIEW IN ETQ. DATA WAS FILTERED TO REMOVE DUPLICATES FROM COMPLAINT NUMBER, ITEM NUMBER, LOT NUMBER AND INITIAL MDR REPORT NUMBER. DATA WAS THEN ANALYZED FOR RELEVANCE (TAB 2). REVIEW OF COMPLAINT HISTORY FOR ITEM # 046W0AN00002 IDENTIFIED 0 ADDITIONAL COMPLAINTS. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY TO REMOVE AN OLD JAVA CONSTRUCT THAT WAS IMPLANTED YEARS EARLIER. THE COMPLAINANT STATED THAT THERE WAS NO FUSION PRESENT AT THE TIME OF REMOVAL AND A NEW CONSTRUCT WAS PLACED TO COMPLETE THE CASE. NO FURTHER SPECIFIC SURGICAL OR PATIENT INFORMATION WAS PROVIDED. THIS IS REPORT TWO OF TEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY TO REMOVE AN OLD JAVA CONSTRUCT THAT WAS IMPLANTED YEARS EARLIER. THE COMPLAINANT STATED THAT THERE WAS NO FUSION PRESENT AT THE TIME OF REMOVAL AND A NEW CONSTRUCT WAS PLACED TO COMPLETE THE CASE. NO FURTHER SPECIFIC SURGICAL OR PATIENT INFORMATION WAS PROVIDED. THIS IS REPORT TWO OF TEN.

    Additional Manufacturer Narrative · 1

    DEVICE PRODUCT CODE: MNH OR NKB. 510(K) NUMBER: K113270 OR K111301 OR K122592 OR K123552. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. REFERENCE REPORTS 3003853072-2019-00102 TO 3003853072-2019-00111.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY TO REMOVE AN OLD JAVA CONSTRUCT THAT WAS IMPLANTED YEARS EARLIER. THE COMPLAINANT STATED THAT THERE WAS NO FUSION PRESENT AT THE TIME OF REMOVAL AND A NEW CONSTRUCT WAS PLACED TO COMPLETE THE CASE. NO FURTHER SPECIFIC SURGICAL OR PATIENT INFORMATION WAS PROVIDED. THIS IS REPORT TWO OF TEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049128 INSTINCT JAVA SCREW, UNKNOWN SIZE INSTINCT JAVA SYSTEM MNH ZIMMER SPINE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R