BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XRL MEDIUM CENTR BOD H44-59

    MDR report key: 3229134 · Received July 16, 2013

    Report

    Report Number
    2520274-2013-04266
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 21, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    MQP
    PMA / PMN Number
    K103320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    LOT # 7100584.SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS.H10 ADDITIONAL NARRATIVE:(B)(4)

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: AN INVESTIGATION OF THE COMPLAINED PACKAGING SHOWED THAT THE LABEL DOES NOT CORRESPOND TO PRODUCT SPECIFICATIONS. THIS IS AN ERROR IN THE LABELING PROCESS. A STEP IN THE PROCESS WAS NOT PERFORMED CORRECTLY.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. MANUFACTURE DATE: 12/7/2012. REVIEW OF THE DHR SHOWS NO COMPLAINT RELATED ANOMALIES.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: AFTER FIRST CASE OF XRL, IT WAS OBSERVED THAT THE PRODUCT SIZE ON SOME LABELS (OF THE PEEK VBR IMPLANTS) DOES NOT MATCH WITH THE SIZE DESCRIBED IN THE SURGICAL TECHNIQUE. DEVIATION HAD NO IMPACT TO OUTCOME OF SURGERY, SIZE 3 WAS USED. THIS IS REPORT 6 OF 8 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329995 XRL MEDIUM CENTR BOD H44-59 MQP SYNTHES USA 7100584

    Patients

    Seq Age Sex Outcome Treatment
    1