BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH

    MDR report key: 3230662 · Received July 16, 2013

    Report

    Report Number
    2530088-2013-01063
    Event Type
    Injury
    Date Received
    July 16, 2013
    Report Date
    May 13, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, AL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE HISTORY REPORT REVIEW FOUND 1 NCR FOR DATA ENTRY ERROR IN LIMS BUT NOT FOR THE PART AND LOT NUMBER IN QUESTION. THERE WAS NO NONCONFORMANCE; NCR WAS WRITTEN FOR INVESTIGATION THAT WAS INADVERTENTLY INITIATED IN LIMS BECAUSE OF AN OPERATOR DATA ENTRY ERROR. NCR'S NONCONFORMANCE IS NOT RELEVANT TO COMPLAINT CONDITION. ALSO NOTED IS A DOCUMENTATION ERROR ON INSPECTION SHEET WHERE A GAGE IDENTIFIER WAS NOT FILLED IN BY OPERATOR. A MISSING GAGE IDENTIFIER ON AN INSPECTION SHEET WILL HAVE NO EFFECT ON COMPLAINT CONDITION BECAUSE THIS IS A VISUAL STANDARD FOR AN ANODIZE FINISH FOR A SCREW THAT WILL HAVE NO EFFECT ON DISLODGED LOCKING CAPS OR CAGE MIGRATION. A NOTE TO FILE WILL BE WRITTEN TO CORRECT THIS DEFICIENCY. NO OTHER DISCREPANCIES WERE NOTED THAT WOULD BE ASSOCIATED WITH THIS COMPLAINT. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. (B)(4).

    Additional Manufacturer Narrative · 1

    A PD EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT SIXTEEN PARTS WERE RECEIVED WITH COMPLAINT CATEGORY "IMPLANT MIGRATION". THE LEGAL CONSULTANT REPORTED THAT THE PATIENT EXPERIENCED POST-OPERATIVE PAIN CAUSED BY THE CLICK-X SCREWS BECOMING LOOSE AND THE ROD DISLODGING FROM THE TULIP HEAD OF THE SCREW. THE RODS ARE USED WITH THE MATRIX SPINE SYSTEM-DEGENERATIVE FOR POSTERIOR PEDICLE SCREW AND ROD FIXATION OF THE SPINE. THE LOCKING CAPS ARE USED WIDELY THROUGHOUT SPINE FIXATION SYSTEMS. FOR THE CONTEXT OF THIS COMPLAINT, THE LOCKING CAPS ARE USED IN THE MATRIX SPINE SYSTEM-DEFORMITY FOR POSTERIOR PEDICLE SCREW, HOOK, AND ROD FIXATION OF THE SPINE. THE SPACER IS USED WIDELY THROUGHOUT SPINE FIXATION SYSTEMS. FOR THE CONTEXT OF THIS COMPLAINT, THE SPACER IS USED IN THE MATRIX SPINE SYSTEM- DEGENERATIVE AS A MINIMALLY INVASIVE INSTRUMENT FOR USE WITH THE MATRIX SPINE SYSTEM. THE POLY AX 45MM SCREWS ARE USED WITH THE MATRIX SPINE DEGENERATIVE FOR POSTERIOR PEDICLE SCREW AND ROD FIXATION OF THE SPINE. THE POLY AX 40MM SCREWS ARE USED WIDELY THROUGHOUT SPINE FIXATION SYSTEMS. FOR THE CONTEXT OF THIS COMPLAINT, THE SCREWS ARE USED WITH THE MATRIX SPINE SYSTEM-DEGENERATIVE FOR POSTERIOR PEDICLE SCREW AND ROD FIXATION OF THE SPINE. FOR PART 04.632.000, THE DESIGN IS DEEMED TO BE ADEQUATE FOR THE INTENDED USE. THE LOOSENING OF THE LOCKING CAPS IS MOST LIKELY DUE TO INSUFFICIENT APPLICATION OF TORQUE APPLIED TO THE LOCKING CAPS BY THE SURGEON DURING THE CONSTRUCT BUT THE LACK OF IMPLANTATION DETAILS OF THE CONSTRUCT DEEM THE DISPOSITION TO BE INDETERMINATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS PERFORMED ON THE RETURNED TI MATRIX POLYAXIAL SCREW. VISUAL INSPECTION REVEALED ON THE BODY OF THE SCREW THERE ARE NICKS, SCRATCHES AND SPOTS ON THE PERIPHERY OF PART WITH HEAVY GRIND MARKS ON LOWER RADIUS RADIATING ONTO THE FLAT, WITH NICK ON LEAD ON INTERNAL THREAD. ON THE COLLET THERE ARE INDICATIONS OF ROD SLIPPAGE ON ONE SIDE ONLY IN THE ROD SLOT WITH A NICK ON INTERNAL DIAMETER IN ROD SLOT AND GRIND MARK ON EXTERNAL SIDE OF ROD SLOT. THE SCREW HAS NICKS AND SCRATCHES ON THE SD25 FACE. DIMENSIONAL MEASUREMENTS WERE WITHIN SPECIFICATION. ALL DESCRIBED NONCONFORMITIES ARE POST MANUFACTURING; COMPLAINT IS INVALID FROM A MANUFACTURING PERSPECTIVE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE DEVICE WAS IMPLANTED AND A REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2013. THE SURGEON STATES THAT THE PATIENT HARDWARE, MATRIX AND TPAL, FROM A L2-L5 TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) PROCEDURE MALFUNCTIONED. THE SURGEON REVIEWED THE LATERAL AND ANTERIOR-POSTERIOR X-RAYS AND NOTICED THAT AT LEAST TWO MATRIX LOCKING CAPS BECAME DISLODGED. THE L4-L5 TPAL CAGE MIGRATED POSTERIORLY. THE SURGEON NOTICED THAT TWO SET SCREWS WERE COMPLETELY DISLODGED (RL2 AND RL5) AND SEVERAL OTHER SCREW SETS WERE LOOSE. THE RIGHT L3, LEFT L4, RIGHT AND LEFT L5 SCREWS WERE REMOVED AND REPLACED WITH LARGER DIAMETER SCREWS. THE L4-L5 TPAL CAGE WAS REMOVED FROM SPINAL CANAL AND REPLACED WITH A LARGER CAGE. NEW RODS AND EIGHT NEW SET SCREWS WERE PLACED WITHIN THE PATIENT. THE SALES CONSULTANT STATES THAT THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. THIS IS 10 OF 15 DEVICES FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 13 OF 16 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329105 6.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH NKB SYNTHES BRANDYWINE 6654366

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention