BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHETIC VERTEFILL(TM) CHRONOS(TM) 15MM DIA-STERILE

    MDR report key: 4509234 · Received February 11, 2015

    Report

    Report Number
    2520274-2015-10897
    Event Type
    Injury
    Date Received
    February 11, 2015
    Report Date
    January 29, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    MQV
    PMA / PMN Number
    PK043045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL PRODUCT CODES ARE APPLICABLE FOR THIS PART. FMF WAS REPORTED IN ERROR. MQV IS THE ONLY ASSOCIATED CODE FOR THIS PART NUMBER. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE HAD SURGERY AT L4-5 DUE TO BACK PAIN AND DEGENERATIVE DISC DISEASE ON (B)(6) 2014. A SYNFIX-LR DEVICE WAS IMPLANTED AT THE L4-5 LEVEL PACKED WITH AUTOGRAFT FROM THE L5 VERTEBRAL BODY. A TREPHINE SET AND A CHRONOS 15 MM VERTEFILL IMPLANT WERE USED. ON AN UNKNOWN DATE, THE PATIENT RETURNED TO HIS PHYSICIAN COMPLAINING OF BACK PAIN. THE PATIENT REPORTED THAT HE SAT DOWN HARD AND FELT A POP IN HIS BACK. ON IMAGING (UNKNOWN TYPE) AN L5 FRACTURE WAS IDENTIFIED. ON AN UNSPECIFIED DATE, THE PATIENT HAD A DEXA SCAN PERFORMED THAT REVEALED OSTEOPOROSIS. IN ADDITION, THE PATIENT WAS TAKING STEROIDS FOR AN UNSPECIFIED CONDITION. THE SURGEON STATED THAT HE THOUGHT THE PATIENT¿S OSTEOPOROSIS WAS THE ISSUE AND THAT HE WAS NOT AWARE OF THE MAGNITUDE OF THE PATIENT¿S POOR BONE QUALITY PRIOR TO THE INITIAL SURGERY, AND THAT HE WOULD NOT HAVE USED THE VERTEFILL IN THE L5 BODY. THERE WERE NO FAILURES OF THE HARDWARE FROM THIS SURGERY. ON (B)(6) 2015 DURING THE OPERATIVE REVISION, THE SURGEON INSTRUMENTED THE PATIENT POSTERIORLY WITH USS DUAL OPENING FROM L4-S1 (SKIPPED L5 LEVEL). THE PATIENT WAS THEN FLIPPED TO THE ANTERIOR POSITION. THE SYNFIX SPACER WAS REMOVED WITHOUT INCIDENT AND A CORPECTOMY WAS PERFORMED AT L5. A SYNTHES XRL EXPANDABLE CAGE WAS IMPLANTED AT THE L5 LEVEL. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT IS AGAINST ONE SYNFIX-LR SPACER, FOUR SYNFIX SCREWS, AND ONE CHRONOS SYNTHETIC VERTEFILL. THIS REPORT IS 6 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101351 SYNTHETIC VERTEFILL(TM) CHRONOS(TM) 15MM DIA-STERILE FILLER, CALCIUM SULFATE PREFOR MED PELLETS MQV SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention