BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC CERVICAL MEDIUM DEEP/5MM-STERILE

    MDR report key: 1982271 · Received January 31, 2011

    Report

    Report Number
    2520274-2011-00012
    Event Type
    Injury
    Date Received
    January 31, 2011
    Report Date
    January 11, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    MJO
    PMA / PMN Number
    P070001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF REMOVAL IS UNK. MANUFACTURE SITE AND MANUFACTURE DATE CANNOT BE DETERMINED WITHOUT A LOT NUMBER. INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN. NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    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 USED IN TREATMENT NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT INFORMATION PROVIDED: HEIGHT = (B)(6); BMI = (B)(6). MANUFACTURING DATE = MAR 19, 2004. CORRECTED DATA: CORRECTED TO (B)(6) YEARS OLD; (B)(4). 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

    IDE PT WAS BEING TREATED FOR PAIN WITH NARCOTICS, ANTI-INFLAMMATORIES AND PHYSICAL THERAPY FOR MORE THAN A YEAR. PT WAS IMPLANTED PRODISC-C AT C5-C6. PT RETURNED FOR FOLLOW-UP VISIT 6 YEARS POST IMPLANT, STATING SHE IS STILL EXPERIENCING INCAPACITATING NECK PAIN AND UPPER EXTREMITY PAIN. EXAMINATION FOUND NO PAIN OR TENDERNESS DURING PALPATION OF THE PARASPINAL MUSCLES, NO SENSORY DEFICITS APPRECIATED IN EITHER RIGHT OR LEFT UPPER EXTREMITY. NO EVIDENCE OF COMPRESSIVE NEUROPATHY. SHOULDER NEGATIVE IMPINGEMENT SIGN, NO ROTATOR CUFF PATHOLOGY. FULL AND UNRESTRICTED ROM. NEGATIVE. DYSPHAGIA/HOARSENESS: THORACIC SPINE GROSSLY NORMAL. LUMBAR SPINE GROSSLY NORMAL WITHOUT ANY SIGNIFICANT ANATOMICAL ABNORMALITIES. LOWER EXTREMITIES: NO CLONUS (RIGHT SIDE NEGATIVE, LEFT SIDE NEGATIVE), NO PATHOLOGIC REFLEXES, AND NO HYPERREFLEXIA. THE PT HAS NO GAIT DISTURBANCE. PLAIN RADIOGRAPHS WERE REVIEWED AND SHOW THAT THE PRODISC IS INTACT AND THERE IS NO HETEROTOPIC OSSIFICATION. PT STATUS POST ARTIFICIAL DISC REPLACEMENT, C5-6, DONE IN 2004; NEW ONSET OF NECK PAIN AND UPPER EXTREMITY PAIN, INCAPACITATING IN NATURE; ADJACENT LEVEL DISEASE AT C6-7 WITH DEGENERATIVE DISC DISEASE. PT PRESENTED FOR FOLLOW-UP OF MRI. MRI SHOWS A RIGHT C6-C7 HERNIATION. PLAIN RADIOGRAPHS TAKEN SHOW KYPHOTIC DEFORMITY OF THE IMPLANT. KYPHOSIS OF THE PRODISC IMPLANT AND DEGENERATIVE DISC DISEASE WITH A DISC HERNIATION AT C6-7, AND A NORMAL EMG. PT WILL BE REVISED AND PRODISC-C IMPLANT WILL BE REMOVED FOLLOWED BY AN ANTERIOR CERVICAL DISCECTOMY OF C6-7 AND THEN A FUSION C5-7.

    Description of Event or Problem · 1

    PATIENT WAS RETURNED TO THE OPERATING ROOM FOR REVISION. THE PRODISC-C AT C5-C6 WAS REMOVED AND REPLACED WITH A 6MM BIOLOGICAL SPACER CONTACT. SURGEON THEN PERFORMED A BILATERAL C7 NERVE ROOT DECOMPRESSION, SPINAL CORD DECOMPRESSION AND PLACED A 7MM BIOLOGICAL SPACER. SURGEON THEN PLATED THE PATIENT WITH A CERVICAL PLATE SPANNING C5-C6, C6-C7.

    Description of Event or Problem · 1

    01/05/2016 UPDATE: ETQ COMPLAINT UPDATE ASSOCIATED WITH NETREG COMPLAINT #(B)(4) CATSWEB (CW) COMPLAINT #(B)(4). REASON FOR CW #7152: NECK PAIN, UPPER EXTREMITY PAIN, AND REVISION SURGERY. NEW INFORMATION RECEIVED: RADIOLOGY IMAGING, OTHER RELEVANT HISTORY, DEVICE INFORMATION. THIS IS MW FOLLOW-UP #3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRODISC CERVICAL MEDIUM DEEP/5MM-STERILE PROSTHESIS, INTERVERTEBRAL DISC MJO SYNTHES HAGENDORF NA 2004000478

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention