BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE, J6, STAGE 2, LOWER SET, UPPER

    MDR report key: 8758745 · Received July 3, 2019

    Report

    Report Number
    3005985723-2019-00491
    Event Type
    Malfunction
    Date Received
    July 3, 2019
    Date of Event
    June 26, 2019
    Report Date
    September 9, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: MPS REPORTED JOINT ANGLE INCONSISTENT ERROR, FAIL ON M6. DEVICE EVALUATION AND RESULTS: PER (B)(4): FSE RECABLED J6 TRANSMISSION CABLES. SYSTEM WAS FOUND TO BE WITHIN MAKO TOLERANCES AND SPECIFICATIONS. PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ON 11/11/11 (B)(4) DEVICE WAS INSPECTED AND (B)(4) DEVICE WAS PLACED ON: NPR 11-08-0127, NPR 11-09-0016, NPR 11-09-0018, NPR 11-10-086, NPR 11-11-0051; NPR 11-11-0040, NPR 11-11-0021, NPR 11-11-0009, NPR 11-11-0019. A REVIEW OF THE DATA REVEALED THAT THE NON-CONFORMANCES ARE NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 201913 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: SYSTEM READY FOR CLINICAL USE. CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD.

    Description of Event or Problem · 0

    CASE NUMBER: (B)(4), MPS REPORTED JOINT ANGLE INCONSISTENT ERROR, FAIL ON M6. CASE TYPE: TKA. SURGERY WAS NOT COMPLETED ROBOTICALLY. UPDATE: SURGICAL DELAY 30 MIN.

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    CASE NUMBER: (B)(4), MPS REPORTED JOINT ANGLE INCONSISTENT ERROR, FAIL ON M6. CASE TYPE: TKA. SURGERY WAS NOT COMPLETED ROBOTICALLY. UPDATE: SURGICAL DELAY 30 MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551305 CABLE, J6, STAGE 2, LOWER SET, UPPER STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization