BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8.0MM TI MATRIX POLYAXIAL SCREW 70MM THREAD LENGTH

    MDR report key: 3345921 · Received September 12, 2013

    Report

    Report Number
    2530088-2013-01154
    Event Type
    Injury
    Date Received
    September 12, 2013
    Report Date
    August 14, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. DEVICE HISTORY REVIEW FOUND 1 NCR (1056525) FOR D4 OVER-SIZED ¿ PART NO. 04.632.870, LOT #6796623 COMPONENT 04.632.420.2 LOT #6799245. PARTS WERE ACCEPTED BY PD AND DETERMINED TO BE USE AS IS (REF. STOCK HOLD #(B)(4)). NCR'S NONCONFORMANCE RELEVANCE IS UNDETERMINED TO COMPLAINT CONDITION BECAUSE TESTING BY PD ESTABLISHED THAT THERE WAS NO STATIC DIFFERENCE BETWEEN IN SPECIFICATION AND OUT OF SPECIFICATION PRODUCT, BASED ON ANALYSIS AND TESTING PRODUCT DETERMINATION WAS USED AS IS. NO OTHER DISCREPANCIES WERE NOTED THAT WOULD BE ASSOCIATED WITH THIS COMPLAINT. A MANUFACTURING EVALUATION WAS CONDUCTED. THE 8.0MM TI MATRIX POLYAXIAL SCREW RECEIVED ASSEMBLED WITH A LOCKING CAP (LOT #1037094) ASSEMBLY FIRMLY ATTACHED HOLDING A CUT-OFF OPEN TAN TRANSVERSE BAR. THERE IS SOME ANODIZE DISCOLORATION ON THE SCREWS BONE THREAD. THERE ARE NICKS AND SCRATCHES ON THE OUTER AREA OF THE BODY. ALL DESCRIBED NONCONFORMITIES ARE POST MANUFACTURING. THIS PRODUCT HAS BEEN ERRONEOUSLY DETERMINED TO BE PART OF THIS SERIES OF COMPLAINTS. THE INITIAL COMPLAINT IS THE PRODUCT CAME LOOSE AND FELL APART AND THE IDENTIFIED PRODUCT IS FIRMLY ASSEMBLED AS A CONSTRUCT THEREFORE, THERE WOULD BE NO RELEVANT DIMENSIONS. ALL MEASUREMENTS THAT COULD BE TAKEN WERE FOUND TO MEET SPECIFICATIONS. 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 8 OF 10 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460053 8.0MM TI MATRIX POLYAXIAL SCREW 70MM THREAD LENGTH NKB SYNTHES BRANDYWINE 6796623

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention