BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, INTERVERTEBRAL DISC

    MDR report key: 4781922 · Received May 19, 2015

    Report

    Report Number
    2520274-2015-13880
    Event Type
    Injury
    Date Received
    May 19, 2015
    Report Date
    April 28, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PP050010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. CHING, A., BIRKENMAIER, C., AND HART, R. (2009). SHORT SEGMENT CORONAL PLANE DEFORMITY AFTER TWO-LEVEL LUMBAR TOTAL DISC REPLACEMENT SPINE 35, 1991-2003. THIS REPORT IS FOR UNKNOWN PRODISC-L DEVICE (SUPERIOR ENDPLATE)/UNKNOWN PART AND LOT NUMBERS. UNKNOWN PART NUMBER. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: CHING, A., BIRKENMAIER, C., AND HART, R. (2009). SHORT SEGMENT CORONAL PLANE DEFORMITY AFTER TWO-LEVEL LUMBAR TOTAL DISC REPLACEMENT SPINE 35, 1991-2003. THE PURPOSE OF THIS ARTICLE WAS TO IDENTIFY POTENTIALLY SIGNIFICANT FAILURE RATE OF 2-LEVEL DISC ARTHROPLASTY DUE TO CORONAL PLANE INSTABILITY. THERE WERE FOUR CASES STUDIES THAT EXPERIENCE FAILURE OF 2-LEVEL DISC ARTHROPLASTY. FOUR PATIENTS WERE REPORTED TO HAVE FAILED 2-LEVEL LUMBAR ARTHROPLASTY. ALL FOUR PATIENTS PRESENTED WITHIN 11 TO 13 MONTHS OF IMPLANTATION WITH INCREASED BACK PAIN AND RADICULAR SYMPTOMS. THE MECHANISM OF FAILURE WAS CORONAL INSTABILITY DUE TO SMALL DEVIATIONS OF THE PROSTHESES FROM A MIDLINE POSITION IN ALL 4 CASES. A (B)(6) MAN WITH COMPLAINTS OF CHRONIC, SEVERE LOW BACK PAIN WAS DIAGNOSED WITH DEGENERATIVE DISC DISEASE AT L4¿L5 AND L5¿S1. HE UNDERWENT A 2-LEVEL TOTAL DISC ARTHROPLASTY WITH PRODISC II (OFF-LABEL). APPROXIMATELY 1 YEAR AFTER HIS ARTHROPLASTIES, THE PATIENT REPORTED INCREASING LOW BACK PAIN AND INTERMITTENT PARESTHESIAS IN HIS FEET, WORSE ON THE RIGHT THAN ON THE LEFT. HIS NEUROLOGIC EXAMINATION WAS NORMAL. LUMBAR RANGE OF MOTION WAS LIMITED BY PAIN IN ALL DIRECTIONS. RADIOGRAPHS SHOWED THE L4¿L5 PROSTHESIS TO BE OFF-CENTER, WITH WHAT APPEARED TO BE APPROPRIATE MIDLINE POSITIONING OF THE L5¿S1 PROSTHESIS. A SIMILAR PATTERN OF CORONAL PLANE TILTING OF THE TOTAL DISC REPLACEMENTS IN OPPOSING DIRECTIONS WAS NOTED ON THE ANTEROPOSTERIOR RADIOGRAPH AND CORONAL CT RECONSTRUCTION. TRANSVERSE CT SCANNING SHOWED MARKED BILATERAL FACET DEGENERATIVE DISEASE AT L5¿S1, WITH MODERATE DEGENERATION OF THE LEFT L4¿L5 FACET. THE PATIENT DID UNDERGO FACET INJECTIONS OF L5¿S1, BUT NOT HAD FURTHER SURGERY. AT HIS MOST RECENT EVALUATION HE RATED HIS BACK PAIN AS 4 TO 6 OUT OF 10. THIS REPORT IS FOR ONE PRODISC-L DEVICE (SUPERIOR ENDPLATE) CONCERNING PAIN (BACK AND LEG), PARESTHESIAS, DEVICE MIGRATION, BILATERAL DEGENRATION DISEASE. THIS IS REPORT 4 OF 12 FOR (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: CHING, A., BIRKENMAIER, C., AND HART, R. (2009). SHORT SEGMENT CORONAL PLANE DEFORMITY AFTER TWO-LEVEL LUMBAR TOTAL DISC REPLACEMENT. SPINE 35, 1991-2003. (USA, (B)(4)). THE PURPOSE OF THIS ARTICLE WAS TO IDENTIFY POTENTIALLY SIGNIFICANT FAILURE RATE OF 2-LEVEL DISC ARTHROPLASTY DUE TO CORONAL PLANE INSTABILITY. THERE WERE FOUR CASES STUDIES THAT EXPERIENCE FAILURE OF 2-LEVEL DISC ARTHROPLASTY. FOUR PATIENTS WERE REPORTED TO HAVE FAILED 2-LEVEL LUMBAR ARTHROPLASTY. ALL FOUR PATIENTS PRESENTED WITHIN 11 TO 13 MONTHS OF IMPLANTATION WITH INCREASED BACK PAIN AND RADICULAR SYMPTOMS. THE MECHANISM OF FAILURE WAS CORONAL INSTABILITY DUE TO SMALL DEVIATIONS OF THE PROSTHESES FROM A MIDLINE POSITION IN ALL 4 CASES. TWO PATIENTS USED SYNTHES DEVICES AND TWO PATIENTS USED A NON-SYNTHES DEVICE. PATIENT 2 WAS A (B)(6) MAN WITH COMPLAINTS OF CHRONIC, SEVERE LOW BACK PAIN WAS DIAGNOSED WITH DEGENERATIVE DISC DISEASE AT L4¿L5 AND L5¿S1. HE UNDERWENT A 2-LEVEL TOTAL DISC ARTHROPLASTY WITH PRODISC II (OFF-LABEL). APPROXIMATELY 1 YEAR AFTER HIS ARTHROPLASTIES, THE PATIENT REPORTED INCREASING LOW BACK PAIN AND INTERMITTENT PARESTHESIAS IN HIS FEET, WORSE ON THE RIGHT THAN ON THE LEFT. HIS NEUROLOGIC EXAMINATION WAS NORMAL. LUMBAR RANGE OF MOTION WAS LIMITED BY PAIN IN ALL DIRECTIONS. RADIOGRAPHS SHOWED THE L4¿L5 PROSTHESIS TO BE OFF-CENTER, WITH WHAT APPEARED TO BE APPROPRIATE MIDLINE POSITIONING OF THE L5¿S1 PROSTHESIS. A SIMILAR PATTERN OF CORONAL PLANE TILTING OF THE TOTAL DISC REPLACEMENTS IN OPPOSING DIRECTIONS WAS NOTED ON THE ANTEROPOSTERIOR RADIOGRAPH AND CORONAL CT RECONSTRUCTION. TRANSVERSE CT SCANNING SHOWED MARKED BILATERAL FACET DEGENERATIVE DISEASE AT L5¿S1, WITH MODERATE DEGENERATION OF THE LEFT L4¿L5 FACET. THE PATIENT DID UNDERGO FACET INJECTIONS OF L5¿S1, BUT NOT HAD FURTHER SURGERY. AT HIS MOST RECENT EVALUATION HE RATED HIS BACK PAIN AS 4 TO 6 OUT OF 10. THIS REPORT IS FOR ONE PRODISC-L DEVICE (SUPERIOR ENDPLATE) CONCERNING PAIN (BACK & LEG), PARESTHESIAS, DEVICE MIGRATION, BILATERAL DEGENERATION DISEASE. THIS IS REPORT 1 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325416 PROSTHESIS, INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention