BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.5MM TI CURVED ROD 125MM

    MDR report key: 3345894 · Received September 12, 2013

    Report

    Report Number
    8030965-2013-04832
    Event Type
    Injury
    Date Received
    September 12, 2013
    Report Date
    August 14, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVENT EVALUATION WAS CONDUCTED AND IT STATES THAT THE FOUR TITANIUM MATRIX LOCKING CAPS (PART 04.632.000) WERE RETURNED WITH THE CONSTRUCT. THE LOCKING CAPS 04.632.000 ARE FOUND IN THE MATRIX SPINE SYSTEM (TECHNIQUE GUIDE J9700 D). THE CAPS INITIALLY LOCK TO THE POLYAXIAL HEAD TO PREVENT THE ROD FROM FULLY RELEASING FROM THE SCREW HEAD WHILE ALLOWING IT TO SLIDE FREELY. WHEN THE CONSTRUCT IS COMPLETE, THE LOCKING CAP IS TIGHTENED WITH A 10NM (03.620.061) IN ORDER FOR THE RODS TO BE FULLY SECURED FOR A RIGID CONSTRUCT. THERE IS SEVERAL LOT NUMBERS ASSOCIATED WITH THE RETURNED LOCKING CAPS (LOT 7003294, 7035943, 7037094, AND 7035940). THE TITANIUM MATRIX LOCKING CAPS WERE RECEIVED ASSEMBLED. THERE ARE NICKS AND SCRATCHES ON THE SD25 (STARDRIVE) FACE DUE TO TOOL ENGAGEMENT. THERE IS NO EVIDENCE OF CROSS THREADING AND THERE IS NO FLATTENING OF THE TEETH ON THE SADDLE INDICATING THE ROD WAS NOT LOOSE ON THE LOCKING CAPS. THE LOCKING CAPS WERE ENGAGED WITH POLYAXIAL SCREW (04.606.665 LOT 6553706) WITH NO DIFFICULTIES OCCURRING DURING ASSEMBLY TO SCREW. A REVIEW OF THE MOST CURRENT EDITION OF THE DESIGN DRAWING WAS PERFORMED AND THERE WERE NO CHANGES MADE TO THE TITANIUM MATRIX LOCKING CAP ASSEMBLY. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RETURNED DEVICE DID NOT DEMONSTRATE THE COMPLAINT CONDITION; THEREFORE, THIS COMPLAINT IS INVALID FROM A DESIGN PERSPECTIVE. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). RECEIVED CONDITION OF THE ROD SHOWS MARKS AND WEAR; ON SOME AREAS THE ANODIZED COLOR HAS COMPLETELY DISAPPEARED; ON ONE SIDE THE ROD WAS CUT OFF AND IT IS BENT. MANUFACTURING EVALUATION WAS CONDUCTED AND THE RELEVANT DIMENSION FOR THIS COMPLAINT MEETS TO THE SPECIFICATION. THE BENDING RADIUS COMPARED WITH THE DRAWING CANNOT BE VERIFIED TO THE SPECIFICATION AS THE ROD WAS CUT OFF. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS IMPLANTED ON (B)(6) 2012 WITH MATRIX CONSTRUCT AT POSITIONS: LUMBAR 4 TO SACRUM 1 AND ILEUM ON BOTH SIDES. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013 FOR REMOVAL OF HARDWARE. X-RAYS CONFIRMED BOTH OF THE LOCKING CAPS AT THE L3 POSITION BACKED OUT. DURING SURGERY IT WAS OBSERVED THAT THE LOCKING CAPS AT THE L4 POSITION WERE LOOSE. PATIENT WAS REVISED TO COMPETITOR¿S HARDWARE. PROCEDURE WAS COMPLETED WITH NO PROBLEMS. THIS IS 10 OF 10 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460014 5.5MM TI CURVED ROD 125MM NKB SYNTHES GMBH 7622115

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention