BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD Ø5.5 SOFT CURV L65 TI

    MDR report key: 3230386 · Received July 16, 2013

    Report

    Report Number
    8030965-2013-04362
    Event Type
    Injury
    Date Received
    July 16, 2013
    Report Date
    June 24, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL INFORMATION RECEIVED. ALTHOUGH THE X-RAY INFORMATION WAS ORIGINALLY PROVIDED ON THE INITIAL REPORT SUBMITTED ON (B)(4) 2013, IT WAS NOT INCLUDED. THIS REPORT DOCUMENTS THE X-RAY INFORMATION. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE ROD SHOWS MARKS AND WEAR; ON SOME AREAS THE ANODIZED COLOR HAS COMPLETELY DISAPPEARED. THE RELEVANT DIMENSIONS FOR THIS COMPLAINT MEET TO THE SPECIFICATION. . THE BENDING RADIUS COMPARED WITH DRAWING 04_636_030 REV. C ALSO MEETS TO THE SPECIFICATION. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DOCTOR USED MATRIX MATERIAL FOR L4-S1 AND T-PAL FOR L5-S1. IMMEDIATELY POST-OP EVERYTHING WAS NORMAL, AND PATIENT WAS RECOVERING NORMALLY ON (B)(6) 2013. ON AN UNKNOWN DATE, THE PATIENT STARTED TO COMPLAIN ABOUT INCREASING BACK PAIN. DURING A NEW CONTROL ON (B)(6) 2013, THEY SAW THAT THE HEADS ARE LOOSENED FROM THE SCREWS ON LEVEL L4. REVISION PLANNED FOR (B)(6) 2013. PATIENT DID NOT DO ANYTHING SPECIAL, NO FALL OR OTHER ACCIDENT. TWO SCREW HEADS WERE SEPARATED FROM THE SHAFT. THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327937 ROD Ø5.5 SOFT CURV L65 TI NKB SYNTHES GMBH 8156543

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention