BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM TI CORTEX EXPANSIONHEAD SCREW SELF-TAPPING 16MM

    MDR report key: 3230976 · Received July 17, 2013

    Report

    Report Number
    2520274-2013-04441
    Event Type
    Injury
    Date Received
    July 17, 2013
    Report Date
    June 21, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    KWP
    PMA / PMN Number
    K994187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE IMPLANT DATE WAS REPORTED AS (B)(6) 2007.

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. THIS DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 1

    PATIENT UNDERWENT INITIAL ACDF WITH ANTERIOR CERVICAL PLATING (C4-C5, C5-C6, AND C6-C7) IN (B)(6) 2007. A CERVICAL SPINE CT ON (B)(6) 2008 REVEALED EVIDENCE OF COLLAPSE OF THE FUSION BONE AT C4-C5 LEVEL WITH ABSENCE OF DEFINITE INCORPORATION OF FUSION BONE AND SOME LUCENCY SURROUNDING THE SCREWS WITHIN THE C4 VERTEBRAL BODY SUGGESTING LOOSENING. THIS WAS SUPPORTED BY THE FACT THAT THE HEADS OF THE SCREWS WERE NOT COMPLETELY FLUSH WITH THE INTERNAL FIXATION PLATES. PER THE SURGEON, HE FELT THE CT DEMONSTRATED A NON-UNION AT C4-C5 AND AT C6-C7. A CERVICAL SPINE X-RAY ON (B)(6) 2008 SHOWED STABLE ANTERIOR FUSION OF C4 THRU C7 WITH ANTERIOR PLATE AND SCREWS AND INTEROSSEOUS BONY FUSION ALONG WITH QUESTIONABLE FUSION AT C4-C5 AND C6-C7. A CERVICAL SPINE X-RAY ON (B)(6) 2011 REVEALED A BROKEN METAL PLATE IN ITS LOWER THIRD ANTERIOR TO THE UPPER ENDPLATE OF C7. A SPINE CT ON (B)(6) 2011 SHOWED C4 THRU C7 ANTERIOR FUSION WITH FRACTURE OF THE ANTERIOR PLATE AT THE C6-C7 LEVEL WITH LACK OF BONY BRIDGING ACROSS THE C6-C7 ENDPLATES AS WELL AS A NON-UNION AT THAT LEVEL. DURING AN OFFICE EXAM ON (B)(6) 2011, SURGICAL OPTIONS WERE DISCUSSED AND AGREED UPON. PER THE PATIENTS CHOICE, THE SURGERY WAS POSTPONED. ON (B)(6) 2011, THE PATIENT UNDERWENT A REDO OF C6-C7 ACDF AND A FIRST TIME C7-T1 ACDF AS WELL AS THE REMOVAL OF THE PREVIOUS PLATING. A SYNTHES TI CERVICAL SPINE LOCKING PLATE 68MM, 8, 4.0MM TI CORTEX EXPANSIONHEAD SCREWS AND 8, 1.8MM TI LOCKING SCREWS WERE EXPLANTED. THE PATIENT WAS REVISED TO A SYNTHES CERVICAL SPINE VARIABLE ANGLE, 2 LEVEL/31MM LOCKING PLATE, 2 SPACERS, 4, 4.5MM TI CANCELLOUS EXPANSIONHEAD SCREWS, 2, 4.0MM TI CANCELLOUS EXPANSIONHEAD SCREWS AND 6, 1.8MM TI LOCKING SCREWS. A POST OP VISIT ON (B)(6) 2012 INDICATED THAT THE PATIENT WAS DOING WELL WITHOUT COMPLAINTS OF PAIN IN HIS NECK OR UPPER EXTREMITIES. THIS IS REPORT 8 OF 17 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331375 4.0MM TI CORTEX EXPANSIONHEAD SCREW SELF-TAPPING 16MM KWP SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention