BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIX LOCKING CAP

    MDR report key: 3151944 · Received June 7, 2013

    Report

    Report Number
    2520274-2013-03190
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    May 13, 2013
    Manufacturer
    SYNHES (USA) 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 USED FOR TREATMENT, NOT DIAGNOSIS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). 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.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. REVIEW OF THE DEVICE HISTORY RECORDS (DHR) SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    MANUFACTURING EVALUATION WAS PERFORMED ON THE RETURNED PARTS. THE TI MATRIX LOCKING CAP WAS RECEIVED WITH SADDLE ASSEMBLED. THE LEAD IN AREA ON THE OUTER DIAMETER THREAD SHOWS SIGNS OF BEING POLISHED WITH ANODIZE BEING WORN OFF, AND THE MAJOR DIAMETER HAS APPROXIMATELY 50% OF FIRST THREAD WITH ANODIZE BEING WORN OFF. THE SADDLE HAS FLATS ON BOTH SIDE OF ROD SLOT INDICATING THAT THE BODY/LOCKING CAP WERE TOGGLING WHILE THE ROD WAS LOOSE. ALL DESCRIBED NONCONFORMITIES ARE POST MANUFACTURING. RAW MATERIAL CANNOT BE ANALYZED BECAUSE THERE IS TOO LITTLE MASS, BUT WAS CONFIRMED AS CORRECT IN DHR. ALL DIMENSIONS ARE WITH SPECIFICATION; COMPLAINT IS INVALID FROM A MANUFACTURING PERSPECTIVE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A TLIF PROCEDURE WITH MATRIX AND T-PAL AT L2-L5 ON (B)(6) 2011. X-RAYS TAKEN ON AN UNKNOWN DATE SHOW AT LEAST TWO MATRIX LOCKING CAPS HAVE BECOME DISLODGED AND THE L4-L5 T-PAL SPACER HAS MIGRATED POSTERIORLY AND IS NOW IN THE SPINAL CANAL. PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2013 FOR REVISION. THIS REPORT IS 3 OF 3 FOR (B)(4).

    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 & 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 1 OF 16 DEVICES FOR THIS EVENT REPORTED ON (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 3 OF 15 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 3 OF 16 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253276 TI MATRIX LOCKING CAP NKB SYNHES (USA) BRANDYWINE 6690860

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention