|
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for an unknown vectra construct/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is j&j company representative.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.
|
|
This report is being filed after the review of a clinical evaluation report (cer) from a database related research activity (drra) from carilion clinic.A total of 50 patients implanted with acis and vectra devices were included in the study cohort.There were more male patients (58%) than female patients (42%).The mean patient age was 53.5 years (range: 37 to 84 years).The majority of patients received treatment with 2 acis devices (54%), followed by 1 acis device (38%), and 3 acis devices (8%).All patients were treated with pedicle screws/ rods (synthes, ltd), and vectra plate.The following complications and adverse events per identifier have been identified as follows in the initial report: a (b)(6) female patient (bmi = (b)(6)) reports continued muscle tightness in neck shoulders and traps and referred to pain management.The patient states ever since surgery, bilateral hands will randomly jump/twitch.She also stated that she has continued muscle tightness and soreness into bilateral sides and posterior aspects of her neck.A (b)(6) patient (bmi = (b)(6)) experienced sharp pains in neck, and back; pain, difficulty swallowing; strangling feeling when lying down; complaints of some issues with swallowing.A (b)(6) patient (bmi = (b)(6)) experienced neck and shoulder pain; shoulder and neck pain continuing.A (b)(6) patient (bmi = (b)(6)) experienced difficulty swallowing since surgery has improved; neck pain and numbness/ tingling down arms; had complaints of some tingling in the left arm that is mod and intermittent neck pain; chronic and moderate left shoulder pain that is intermittent; still experiencing neck pain.A (b)(6) patient (bmi = (b)(6)) experienced pain in both shoulders; pain swallowing.A (b)(6) patient (bmi = (b)(6)) experienced cervical pain and shoulder pain after initial improvement; neck pain, left to right pain radiating to wrist.A (b)(6) patient (bmi = (b)(6)) experienced postop delirium prior to discharge; return of back pain and jerking of leg/ feet.A (b)(6) patient (bmi = (b)(6)) experienced difficulty swallowing prior to discharge; neck pain due to fall; neck pain; worsening neck pain; continued neck pain.A (b)(6) patient (bmi = (b)(6)) experienced difficulty swallowing at 6 week postop.A (b)(6) patient (bmi = (b)(6)) had syncope episode prior to discharge.A (b)(6) patient (bmi = (b)(6)) continues to have right neck and shoulder, pulling pain/pressure; when gets bad pain goes to the left shoulder; pain (b)(6) 2010.A (b)(6) patient (bmi = (b)(6)) had difficulty swallowing at 6 week postop; had continued neck and right arm pain.A (b)(6) patient (bmi = (b)(6)) had difficulty swallowing at 6 week postop; neck and right arm pain; cervical pain with right arm pain that is chronic and severe.A (b)(6) patient (bmi = (b)(6)) had moderate neck stiffness at 3 month postop.A (b)(6) patient (bmi = (b)(6)) had an ed admission for tracheotomy, peg placement, hematoma in neck exploration and evacuation on 4-3-2018; had lower cervical pain at 3 month postop; cervical pain and left arm pain that is chronic at 6 month postop.A (b)(6) patient (bmi = (b)(6)) had an ed visit on (b)(6) 2018 because patient fell backward and hit back of head, cervical pain and right arm pain; neck pain and nerve injury at 3 months postop; neck pain, nerve damage, pain radiating down left arm with numbness and tingling.A (b)(6) patient (bmi = (b)(6)) had neck pain post surgical flare up; patient fell in tub (b)(6) 2017 and hit head/neck.A (b)(6) patient (bmi = (b)(6)) had difficulty swallowing prior to discharge.A (b)(6) patient (bmi = (b)(6) had difficulty swallowing at 6 week postop.A (b)(6) patient (bmi = (b)(6)) had difficulty swallowing prior to discharge; at 6 week postop had left arm pain at 2 week follow up, resolving.A (b)(6) patient (bmi = (b)(6)) had pain and difficulty swallowing prior to discharge; had cervical pain with radiating pain down right arm.A (b)(6) patient (bmi = (b)(6)) had anterior neck hematoma evacuation.A (b)(6) patient (bmi = (b)(6)) had difficulty swallowing prior to discharge; at 6 week postop had continued difficulty swallowing, neck pain, arm tingling; at 3 month postop had continued neck pain and right shoulder pain; at 6month postop had continued difficulty swallowing, neck pain, arm tingling; a (b)(6) patient (bmi = (b)(6)) had difficulty swallowing at 6 week postop which continued to 12 month postop.A (b)(6) patient (bmi = (b)(6)) had pain and difficulty swallowing prior to discharge; at 3month postop had cervical stiffness.A (b)(6) patient (bmi = (b)(6)) had pain and difficulty swallowing prior to discharge which continued upto 6 week postop; neck pain was also noted at 6 week postop; at 3month postop had continued neck pain, difficulty swallowing; at 6month postop had continued difficulty swallowing, neck pain, right arm weakness, pain; at 12month postop had continued neck and right arm weakness.A (b)(6) patient (bmi = (b)(6)) had debilitating neck and arm pain; underwent cervical decompression.A (b)(6) patient (bmi = (b)(6)) had incision pain at 6 week postop; at 3month postop still some anterior surgical site pain; experienced debilitating neck pain; underwent revision surgery (revision plating screws).A (b)(6) patient (bmi = (b)(6)) had difficulty swallowing prior to discharge a (b)(6) patient (bmi = (b)(6) ) had difficulty swallowing prior to discharge; at 6week postop had continued difficulty swallowing; a (b)(6) patient (bmi = (b)(6) ) had difficulty swallowing prior to discharge; at 6 week postop had previous trouble swallowing, pain in both shoulders.In a (b)(6) patient (bmi = (b)(6) ), chronic and severe cervical pain surgery has improved at 6week postop; at 3month postop cervical pain and arm pain have improved.A (b)(6) patient (bmi = (b)(6) ) had fall back in june; continued neck and shoulder pain, tingling/ numbness in arms at 12 month postop.A (b)(6) patient (bmi = (b)(6) ) had neck pain, stiffness, difficulty swallowing, chest pain prior to discharge; at 3month postop had continued neck pain, shoulder pain; at 6month postop had chronic right shoulder pain; at 12month postop had cervical pain and burning stinging pain in all extremities.A (b)(6) patient (bmi = (b)(6) ) had neck pain and difficulty swallowing prior to discharge; at 6week postop had continued difficulty swallowing, neck pain.A (b)(6) patient (bmi = (b)(6) ) had shoulder pain at 6 week postop; at 6month postop had continued worsening neck pain; at 12month postop had cervical and left side pain.A (b)(6) patient (bmi = (b)(6) ) had difficulty swallowing prior to discharge; at 3month postop had continued neck pain, shoulder pain; at 12month postop had significant amount of neck and back pain.Posterior neck pain that radiates into his shoulders.Down back of both arms, worse on the right side; numbness in both hands.A (b)(6) patient (bmi = (b)(6)) had difficulty swallowing prior to discharge a (b)(6) patient (bmi = (b)(6)) had intraoperative sagittal midline nondisplaced fracture through c5 vertebral body; at 6week postop had continued right arm tingling; at 3month postop had continued right arm tingling and intermittent pain.A (b)(6) patient (bmi = (b)(6)) had difficulty swallowing large pills or meat and neck stiffness at 3 month postop; at 6month postop had continued difficulty swallowing, neck stiffness, soreness; at 12month postop had posterior neck spasms.A (b)(6) patient (bmi = (b)(6)) had constant ache posterior neck, head, and shoulders at 3month postop.A (b)(6) patient (bmi = (b)(6)) had new neck pain due to mvc in parking lot, neck snapped back and patient was sent to ed.The following were reported in the ai (some patients cannot be identified which ae they belong as the ae/number of count reported below did not coincide above), which were as follows: intraoperative sagittal midline nondisplaced fracture through c5 vertebral body: device related: 1 patient - that resolved before 3 months a (b)(6) patient (bmi = (b)(6)).Deep vein thrombosis: procedure related: 1 patient - that resolved before 3 months.Post-operative delirium: procedure related: 1 patient - that resolved before 3 months.A (b)(6) patient (bmi = (b)(6)).Syncope episode: procedure related: 1 patient - that resolved before 3 months.A (b)(6) patient (bmi = (b)(6)).Dysphagia: procedure related: 17 patients - that resolved before 3 months.5 patients - that resolved after 3 months.1 patient - ongoing.1 patient - unknown status.Neck pain: procedure related: 1 patient - that resolved before 3 months.1 patient - that resolved after 3 months.29 patients - ongoing.1 patient - unknown status.Neck pain: device related: 1 patient - resolved before 3 months.Shoulder pain: procedure related: 6 patients - resolved before 3 months.3 patients - resolved after 3 months.5 patients - ongoing.1 patient - unknown status.Arm pain: procedure related: 4 patients - resolved before 3 months.1 patient - resolved after 3 months.3 patients - ongoing.1 patient - unknown status.Arm pain: device related: 1 patient - resolved before 3 months.Radiculopathy: procedure related: 2 patients - resolved after 3 months.12 patients - ongoing.1 patient - unknown status.Muscle tightness: procedure related: 3 patients - resolved before 3 months.2 patients - ongoing.1 patient - unknown status.A (b)(6) female patient (bmi = (b)(6)).Nerve damage: procedure related: 2 patients - ongoing.1 patient - unknown status.A (b)(6) patient (bmi = (b)(6)).Paresthesia: procedure related: 2 patients - resolved before 3 months.1 patient - resolved after 3 months.2 patients - ongoing.1 patient - unknown status.Bilateral hand twitch: procedure related: 1 patient - resolved before 3 months.1 patient - unknown.A (b)(6) female patient (bmi = (b)(6)).Underwent reoperations due to: 2 patients - anterior neck hematoma evacuation.A (b)(6) patient (bmi = (b)(6)).1 patient - spine irrigation and debridement (hematoma removal).A (b)(6) patient (bmi = (b)(6)).1 patient - cervical decompression (related to adjacent level disease) a (b)(6) patient (bmi = (b)(6)).Underwent revision: revision plate/screw (resolved after surgery); vectra related a (b)(6) patient (bmi = (b)(6)).This is report 6 of 14 for (b)(4).This report is for unknown vectra construct ((b)(6) -pain, hematoma).This complaint is linked to (b)(4).A copy of the clinical evaluation form is being submitted with this regulatory report.
|
