BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI STERNAL LOCKING STAR PLATE-12 HOLES

    MDR report key: 3110590 · Received May 14, 2013

    Report

    Report Number
    3003506883-2013-00221
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    April 16, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K093772
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE COMPLAINT IS DETERMINED TO BE INVALID BASED ON THE DEVICE HISTORY RECORD REVIEW. PLACEHOLDER.

    Description of Event or Problem · 1

    IT IS REPORTED THAT AN EMERGENCY RELEASE PIN BROKE OFF AND MIGRATED AWAY FROM A STERNAL PLATE. A SMALL INCISION WAS MADE TO REMOVE THE PIN AND INSERT A NEW ONE. PATIENT INITIALLY COMPLAINED OF A BULGE IN HIS CHEST. HE PREVIOUSLY UNDERWENT A TRANSVERSE STERNOTOMY IN ORDER TO RECEIVE A LUNG TRANSPLANT. A CT SHOWED THAT THE STERNAL PLATE HAD COME APART, SO THE SURGEON MADE AN APPROXIMATELY THREE TO FOUR INCH INCISION AND DISCOVERED THAT THE PIN HAD COMPLETELY MIGRATED FROM THE PLATE. THE SURGEON REMOVED THE PIN AND IMPLANTED A NEW ONE. THERE IS A TAB THAT SECURES THE PIN TO THE PLATE WHICH WAS MISSING FROM THE PIN. THE SURGEON DECIDED IT WOULD BE MORE HARMFUL TO SEARCH FOR THE TAB INSIDE THE PATIENT THAN IT WOULD BE TO LEAVE IT IMPLANTED, SO THE TAB WAS NOT RETRIEVED. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212455 TI STERNAL LOCKING STAR PLATE-12 HOLES HRS SYNTHES ELMIRA 7183993

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention