BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIRECTINJECT ON DEMAND HA CEMENT

    MDR report key: 5494190 · Received March 10, 2016

    Report

    Report Number
    0008010177-2016-00037
    Event Type
    Injury
    Date Received
    March 10, 2016
    Date of Event
    January 11, 2016
    Report Date
    September 29, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-LIMERICK
    Product Code
    GXP
    PMA / PMN Number
    K143661
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE IS STILL IMPLANTED.

    Additional Manufacturer Narrative · 1

    A CONFIRMATION OF THE REPORTED EVENT WAS NOT APPLICABLE BECAUSE THE COMPLAINED DEVICE WAS NOT RETURNED AND NOT ENOUGH DETAILS WERE PROVIDED. THE CEMENT IS NOT INTENDED TO SEAL CSF LEAKS. THIS IS NOT LISTED IN THE INTENDED USE/INDICATIONS FOR USE. DUE TO THE FLUID COLLECTION (CSF LEAK) THE COMPLAINED DIRECTINJECT¿S SIDE EFFECTS ARE NOT KNOWN (S. IFU-WARNING:DO NOT MIX DIRECTINJECT WITH ANY OTHER SUBSTANCE OR DRUG, SUCH AS ANTIBIOTICS, SERUM OR BLOOD. POTENTIAL SIDE EFFECTS ARE NOT KNOWN AND COULD PUT THE HEALTH OF THE PATIENT AT RISK.) FURTHERMORE THE SUCTION/DRAINAGE OF ACCUMULATED FLUID IN THE SURROUNDING AREA IS RECOMMENDED PRIOR TO PLACEMENT OF THE CEMENT. MOST LIKELY THE DIZZINESS OF THE PATIENT IS A RESULT OF THE LOW CSF PRESSURE (DUE TO THE CSF LEAKAGE). BASED ON THE EVALUATION NO INDICATIONS FOR ANY DESIGN, MATERIAL OR MANUFACTURING RELATED PROBLEMS WERE FOUND IN THIS INVESTIGATION. THEREFORE NO FURTHER CORRECTIVE AND/OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THAT TIME. DEVICE NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    DURING A TELECONFERENCE WITH A SURGEON IN REGARD TO (B)(4), THE SURGEON STATED THERE WAS A FEMALE PATIENT THAT RETURNED TO HIM APPROXIMATELY 4 WEEKS AFTER A CRANIAL PROCEDURE WITH COMPLAINTS OF DIZZINESS. A POSTOPERATIVE CT SCAN WAS PERFORMED, BUT THE RESULTS ARE NOT BACK. THE SURGEON FURTHER STATED HE DID USE DIRECTINJECT IN THIS PROCEDURE, HOWEVER, AT THIS TIME THERE WERE NO SPECIFIC COMMENTS ON THE QUALITY, DURABILITY, OR PERFORMANCE OF THE PRODUCT. ADDITIONALL, THE SURGEON STATED IT IS STANDARD PRACTICE FOR HIM TO APPLY BONE CEMENT TO A DEFECT, TYPICALLY FOLLOWED BY TITANIUM MESH, FOLLOWED BY ANOTHER LAYER OF BONE CEMENT. IT WAS CONFIRMED THAT THERE WILL BE A REVISION SURGERY PERFORMED.

    Description of Event or Problem · 1

    DURING A TELECONFERENCE WITH A SURGEON IN REGARD TO PI 1103743 AND 1103860, THE SURGEON STATED THERE WAS A FEMALE PATIENT THAT RETURNED TO HIM APPROXIMATELY 4 WEEKS AFTER A CRANIAL PROCEDURE WITH COMPLAINTS OF DIZZINESS. A POSTOPERATIVE CT SCAN WAS PERFORMED, BUT THE RESULTS ARE NOT BACK. THE SURGEON FURTHER STATED HE DID USE DIRECT INJECT IN THIS PROCEDURE, HOWEVER, AT THIS TIME THERE WERE NO SPECIFIC COMMENTS ON THE QUALITY, DURABILITY, OR PERFORMANCE OF THE PRODUCT. ADDITIONALLY, THE SURGEON STATED IT IS STANDARD PRACTICE FOR HIM TO APPLY BONE CEMENT TO A DEFECT, TYPICALLY FOLLOWED BY TITANIUM MESH, FOLLOWED BY ANOTHER LAYER OF BONE CEMENT. IT WAS CONFIRMED THAT THERE WILL BE A REVISION SURGERY PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149804 DIRECTINJECT ON DEMAND HA CEMENT IMPLANT GXP STRYKER ORTHOPAEDICS-LIMERICK POSSIBLY DI15313, DI15322

    Patients

    Seq Age Sex Outcome Treatment
    1 Other