BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI MATRIX POLYAXIAL SCREW 45MM THREAD LENGTH

    MDR report key: 4770054 · Received May 13, 2015

    Report

    Report Number
    2530088-2015-10266
    Event Type
    Injury
    Date Received
    May 13, 2015
    Report Date
    April 21, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    PK100952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. AGE NOT DETERMINED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE MANUFACTURE DATE: 05-31-11. REVIEW OF THE DHRS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE DRAWING FOR THE MATRIX 5.5MM ROD WAS REVIEWED (04_633_292 REVISION D). THE MANUFACTURING DATE FOR THE INITIAL ROD FOR WHICH THE LOT NUMBER WAS LEGIBLE (8/25/2011) WAS UTILIZED TO DETERMINE THE PROPER REVISION (D). THE DESIGN, MATERIALS (TI4) AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. THE RETURNED ROD SEGMENTS WERE EXAMINED UNDER MAGNIFICATION. TYPICAL WEAR CONSISTENT WITH IMPLANTATION WAS NOTED; ADDITIONAL SEVERE WITNESS MARKS WERE VISIBLE ON MULTIPLE SEGMENTS WHICH ARE CONTRIBUTABLE TO EXPLANATION WITH AN UNKNOWN DEVICE. MULTIPLE FRACTURE PATTERNS ARE PRESENT ON THE SEGMENTS. SOME SHOW ¿SHINY¿ AND SMOOTH FRACTURE SURFACES CONSISTENT WITH BRITTLE/OVERLOAD FRACTURES, WHILE OTHERS DISPLAY THE CHARACTERISTICS OF DUCTILE FAILURE (DULL AND ROUGH). AS THE RODS HAVE MULTIPLE FRACTURES, IT IS NOT POSSIBLE TO DISTINGUISH THE INITIAL FRACTURE ((B)(6) 2012) FROM THE SECONDARY FRACTURES ((B)(6) 2013). THE COMPLAINT IS CONFIRMED AS THE CONDITION OF BROKEN POST-OPERATIVELY WAS ABLE TO BE CONFIRMED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT IS REPORTED PATIENT WAS IMPLANTED WITH UNKNOWN TITANIUM RODS ON (B)(6) 2012 FROM T11 TO S1. PATIENT REPORTED FEELING A "POP" IN (B)(6) 2012 WITH SUBSEQUENT PAIN THREE (3) DAYS LATER. X-RAYS TAKEN AT THAT TIME REVEALED ONE OF THE RODS HAD BROKEN. NO MEDICAL INTERVENTION WAS PLANNED AT THAT TIME. IT IS REPORTED PATIENT HEARD ANOTHER LOUD POP ON (B)(6) 2012. ADDITIONAL X-RAYS REVEALED THE OTHER ROD HAD BROKEN. PATIENT WAS RETURNED TO OR ON (B)(6) 2013 WHERE SURGEON ADDED TWO SUPPORT RODS. IT IS REPORTED THE BROKEN RODS WERE NOT EXPLANTED AT THAT TIME. A FEW WEEKS LATER PATIENT REPORTS SQUATTING DOWN AND HEARING ANOTHER POP. PATIENT WAS RETURNED TO OR ON (B)(6) 2014 WHERE ALL HARDWARE WAS REMOVED AND PATIENT WAS REVISED TO A NEW ROD CONSTRUCT. IT IS REPORTED THE TWO INITIAL RODS WERE BROKEN IN TWO PLACES, THE SUPPORT RODS ARE INTACT. THIS COMPLAINT IS TO ADDRESS THE SECOND REVISION WHERE ALL HARDWARE WAS EXPLANTED. FIRST REVISION IS ADDRESSED IN (B)(4). THIS REPORT IS 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313998 6.0MM TI MATRIX POLYAXIAL SCREW 45MM THREAD LENGTH ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES BRANDYWINE 6679661

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention