BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    MDR report key: 3231238 · Received July 17, 2013

    Report

    Report Number
    2520274-2013-04280
    Event Type
    Injury
    Date Received
    July 17, 2013
    Report Date
    June 24, 2013
    Manufacturer
    SYNTHES USA
    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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A MANUFACTURING EVALUATION WAS CONDUCTED. THE REPORT INDICATES THE PEDICLE SCREW MATRIX 5.5 POLYAXIAL WAS RECEIVED WITH COLLET ATTACHED TO BODY AND SCREW MISSING FROM ASSEMBLY. THERE IS UNEVEN WEAR IN THE COLLET ROD SLOT INDICATING THAT THE ROD WAS NOT IN ALIGNMENT WITH BODY SHOWN BY UNEVEN SLIDING MOTION IN ROD SLOT - WEAR (LOOKING FROM THE TOP) IS ON TOP LEFT AND BOTTOM RIGHT, NOT CENTER. THERE SHOULD BE NO INDICATIONS OF ROD SLIPPAGE. THERE IS A RUB AREA ON THE BOTTOM OUTER AREA OF THE BODY WHERE THE SCREW HEAD HAS LEFT A BURNISHED AREA. THERE ARE NICKS AND SCRATCHES ON THE OUTER AREA OF THE BODY. EXPECTED TO BE SEEN IS WEAR IN THE COLLET, BUT THERE IS NONE VISIBLE. ALL DESCRIBED NONCONFORMITIES ARE POST MANUFACTURING. THE MEASUREMENT FOR THE COLLET INNER SPHERICAL DIAMETER IS UNOBTAINABLE IN ITS MANUFACTURED SPLIT CONDITION, AND RAW MATERIAL UNOBTAINABLE IN ASSEMBLED CONDITION. RAW MATERIAL WAS VERIFIED AS CORRECT IN DHR REVIEW. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE HISTORY REVIEW FOR THIS LOT HAS BEEN REQUESTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ALTHOUGH THE X-RAY INFORMATION WAS ORIGINALLY PROVIDED IN THE NARRATIVE ON THE INITIAL REPORT SUBMITTED ON (B)(6) 2013, IT WAS NOT INCLUDED IN SECTION RELEVANT TESTS. THIS REPORT DOCUMENTS THE X-RAY INFORMATION IN SECTION RELEVANT TESTS. DATE OF MANUFACTURE OBTAINED FROM REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) 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 1 OF 6 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330586 PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM NKB SYNTHES USA 6997134

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention