BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

    MDR report key: 5297249 · Received December 15, 2015

    Report

    Report Number
    2520274-2015-17894
    Event Type
    Injury
    Date Received
    December 15, 2015
    Report Date
    February 20, 2007
    Manufacturer
    SYNTHES USA
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PATIENT HEIGHT REPORTED AS (B)(6). EVENT DATE: UNKNOWN. THIS REPORT IS FOR AN UNKNOWN ACDF DEVICE/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DURING THE (B)(6) 2005 VISIT, IT WAS NOTED THE IMPLANTS HAD BEEN EXPLANTED; UNKNOWN WHEN EXACTLY THE IMPLANTS WERE EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 WAS REPORTED THAT (B)(4) STUDY PATIENT (B)(6) RECEIVED AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) AT C4-C5 ON (B)(6) 2004. NO INTRAOPERATIVE COMPLICATIONS. PATIENT WAS DISCHARGED TO HOME (B)(6) 2004. NO COMPLICATIONS OBSERVED AT DISCHARGE. STUDY DISPOSITION DATE WAS (B)(6) 2013; PATIENT FINISHED 84 MONTH FOLLOW-UP (B)(6) 2010. THE FOLLOWING ADVERSE EVENTS WERE REPORTED POST-OPERATIVELY: (B)(6) 2008: UNANTICIPATED PATIENT HAD NECK PAIN/DELAYED HEALING. SEVERITY = MODERATE. ACTION REQUIRED = HOME/OFFICE CARE. COURSE OF ACTION = PATIENT TO FOLLOW-UP IN ONE MONTH AND GET FLEXION/EXTENSION CERVICAL X-RAYS. CURRENT STATE= ONGOING. (B)(6) 2005: UNANTICIPATED PATIENT HAD DEGENERATIVE DISC DISEASE (DDD) HERNIATED NUCLEUS PULPOSUS (HNP) C5-C6 LEFT C6 RADICULOPATHY WORSENING OF DDD. SEVERITY = MODERATE. ACTION REQUIRED = RECOMMEND NERVE ROOT BLOCK (NRB) LEFT C6. COURSE OF ACTION = LEFT C6 NRB. CURRENT STATE = ONGOING- MAY HAVE NRB, BUT DESIRES ARTHROPLASTY FOR ADJACENT LEVEL DISEASE. ON (B)(6) 2006: UNANTICIPATED PATIENT PRESENTED NECK PAIN. SEVERITY = SEVERE. ACTION REQUIRED = HOSPITALIZATION WITH SURGERY. COURSE OF ACTION = LEFT C6 NRB. CURRENT STATE = RESOLVEDON (B)(6) 2006- MONITOR PROGRESS AND WILL FOLLOW-UP. ON (B)(6) 2006: UNANTICIPATED STATUS POST ANTERIOR CERVICAL FUSION (ACF) LEFT UPPER EXTREMITY (LUE) PAIN. SEVERITY = MILD. ACTION REQUIRED = HOSPITALIZATION WITH SURGERY. COURSE OF ACTION = LUE PAIN ELECTROMYOGRAM (EMG) LEFT C6 RADICULOPATHY- PATIENT OPTED FOR SURGERY. CURRENT STATE = RESOLVED. ON (B)(6) 2005; NO LUE SYMPTOMS. IMPLANTS EXPLANTED -YES- PLATES REMOVED AND GIVEN TO PATIENT- REMOVED PLATE ACF 5-6. ON (B)(6) 2010: UNANTICIPATED PATIENT HAD RIGHT UPPER EXTREMITY NUMBNESS/RIGHT SHOULDER PAIN. SEVERITY = MILD. COURSE OF ACTION = NRB BILATERAL OR EPIDURAL STEROID BASED ON PAIN DOCTOR'S DISCRETION. PATIENT HAS UNDERGONE SURGERIES AT TWO ADJACENT LEVELS FOR DEGENERATIVE DISC DISEASE (DDD). CURRENT STATE= ONGOING. ON (B)(6) 2010: UNANTICIPATED THE PATIENT HAD NEW ONSET LUE PAIN. SEVERITY = MILD. COURSE OF ACTION = NRB OR EPIDURAL. THIS REPORT IS FOR ADVERSE EVENT: ON (B)(6) 2006, THE PATIENT PRESENTED NECK PAIN. SEVERITY = SEVERE. LIKELIHOOD = UNANTICIPATED. SEVERE/LIFE THREATENING: YES. ACTION REQUIRED = HOSPITALIZATION WITH SURGERY. IMPLANT INVOLVEMENT = NONE. COURSE OF ACTION = LEFT C6 NERVE ROOT BLOCK (NRB). RELATED TO SURGERY = DEFINITELY NOT. RELATED TO IMPLANT = DEFINITELY NOT. CURRENT STATE OF EVENT = RESOLVED ON (B)(6) 2006- MONITOR PROGRESS AND WILL FOLLOW-UP. THIS REPORT IS FOR AN UNKNOWN ACDF DEVICE. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825784 APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention