MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ACIS IMP-STERILE LORDOTIC/SM-8MM HT; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

Model Number 08.843.608S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Complainant part is not expected to be returned for manufacturer review /investigation.Reporter is a j&j employee.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.

Event Description

This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) and dua data listing for the acis retrospective study completed as part of the pmcf plan.The following complications and adverse events have been identified as per carillon clinic emr - retrospective review: id 2: a (b)(6) female patient (bmi = 32.91) 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.Id 3: a (b)(6) patient (bmi = 36.48) experienced sharp pains in neck, and back; pain, difficulty swallowing; strangling feeling when lying down; complaints of some issues with swallowing.Id 4: a (b)(6) patient (bmi = 28.29) experienced neck and shoulder pain; shoulder and neck pain continuing.Id 5: a (b)(6) patient (bmi = 34.2) 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.Id 9: a (b)(6) patient (bmi = 25.5) experienced pain in both shoulders; pain swallowing.Id 10: a (b)(6) patient (bmi = 28.8) experienced cervical pain and shoulder pain after initial improvement; neck pain, left to right pain radiating to wrist.Id 11: a (b)(6) patient (bmi = 25.25) experienced postop delirium prior to discharge; return of back pain and jerking of leg/ feet.Id 13: a (b)(6) patient (bmi = 35) experienced difficulty swallowing prior to discharge; neck pain due to fall; neck pain; worsening neck pain; continued neck pain.Id 18: a (b)(6) patient (bmi = 42) experienced difficulty swallowing at 6 weeks postop.Id 19: a (b)(6) patient (bmi = 28.5) had syncope episode prior to discharge.Id 21: a (b)(6) patient (bmi = 31.7) continues to have right neck and shoulder, pulling pain/pressure; when gets bad pain goes to the left shoulder; pain 7-8/10.Id 25: a (b)(6) patient (bmi = 38.36) had difficulty swallowing at 6 weeks postop; had continued neck and right arm pain.Id 24: a (b)(6) patient (bmi = 33.1) had difficulty swallowing at 6 weeks postop; neck and right arm pain; cervical pain with right arm pain that is chronic and severe.Id 31: a (b)(6) patient (bmi = 27.1) had moderate neck stiffness at 3 months postop.Id 33: a (b)(6) patient (bmi = 22.96) had an ed admission for tracheotomy, peg placement, hematoma in neck exploration and evacuation on (b)(6) 2018; had lower cervical pain at 3 months postop; cervical pain and left arm pain that is chronic at 6 months postop.Id 34: a (b)(6) patient (bmi = 40) 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.Id 35: a (b)(6) patient (bmi = 41.5) had neck pain post-surgical flare up; patient fell in tub (b)(6) 2017 and hit head/neck.Id 37: a (b)(6) patient (bmi = 28.1) had difficulty swallowing prior to discharge.Id 40: a (b)(6) patient (bmi = 30.3) had difficulty swallowing at 6 weeks postop.Id 41: a (b)(6) patient (bmi = 28.18) had difficulty swallowing prior to discharge; at 6 weeks postop had left arm pain at 2 weeks follow up, resolving.Id 43: a (b)(6) patient (bmi = 37.6) had pain and difficulty swallowing prior to discharge; had cervical pain with radiating pain down right arm.Id 44: a (b)(6) patient (bmi = 32.3) had anterior neck hematoma evacuation.Id 45: a (b)(6) patient (bmi = 33.08) had difficulty swallowing prior to discharge; at 6 weeks postop had continued difficulty swallowing, neck pain, arm tingling; at 3 months postop had continued neck pain and right shoulder pain; at 6month postop had continued difficulty swallowing, neck pain, arm tingling.Id 47: a (b)(6) patient (bmi = 27.36) had difficulty swallowing at 6 weeks postop which continued to 12 months postop.Id 52: a (b)(6) patient (bmi = 39.9) had pain and difficulty swallowing prior to discharge; at 3month postop had cervical stiffness.Id 49: a (b)(6) patient (bmi = 31.22) had pain and difficulty swallowing prior to discharge which continued up to 6 weeks postop; neck pain was also noted at 6 weeks 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.Id 53: a (b)(6) patient (bmi = 22.37) had debilitating neck and arm pain; underwent cervical decompression.Id 54: a (b)(6) patient (bmi = 31.2) had incision pain at 6 weeks postop; at 3month postop still some anterior surgical site pain; experienced debilitating neck pain; underwent revision surgery (revision plating screws).Id 55: a (b)(6) patient (bmi = 28.1) had difficulty swallowing prior to discharge id 56: a (b)(6) patient (bmi = 33.4) had difficulty swallowing prior to discharge; at 6week postop had continued difficulty swallowing.Id 58: a (b)(6) patient (bmi = 58.46) had difficulty swallowing prior to discharge; at 6 weeks postop had previous trouble swallowing, pain in both shoulders.Id 59: in a (b)(6) patient (bmi = 31.46), chronic and severe cervical pain surgery has improved at 6week postop; at 3month postop cervical pain and arm pain have improved.Id 61: a (b)(6) patient (bmi = 34.62) had fall back in june; continued neck and shoulder pain, tingling/ numbness in arms at 12 months postop.Id 63: a (b)(6) patient (bmi = 22.5) 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.Id 65: a(b)(6) patient (bmi = 23.1) had neck pain and difficulty swallowing prior to discharge; at 6week postop had continued difficulty swallowing, neck pain.Id 66: a (b)(6) patient (bmi = 37.2) had shoulder pain at 6 weeks postop; at 6month postop had continued worsening neck pain; at 12month postop had cervical and left side pain.Id 67: a (b)(6) patient (bmi = 31.19) 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.Id 69: a (b)(6) patient (bmi = 32.44) had difficulty swallowing prior to discharge id 70: a (b)(6) patient (bmi = 38.36) 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.Id 74: a (b)(6) patient (bmi = 34.7) had difficulty swallowing large pills or meat and neck stiffness at 3 months postop; at 6month postop had continued difficulty swallowing, neck stiffness, soreness; at 12month postop had posterior neck spasms.Id 77: a (b)(6) patient (bmi = 53.11) had constant ache posterior neck, head, and shoulders at 3month postop.Id 78: a (b)(6) patient (bmi = 28.7) had new neck pain due to mvc in parking lot, neck snapped back, and patient was sent to ed.This is for depuy synthes acis cage.This report is for (1) acis imp-sterile lordotic/sm-8mm ht this report is 10 of 20 for (b)(4).This complaint involves 70 ips.Due to a limit of ips per complaint, this will be captured under 4 separate pcs: (b)(4) - includes 20 ips (1st pc).(b)(4)- includes 20 ips (3rd pc).(b)(4)- includes 10 ips (4th pc).

Manufacturer Narrative

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.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.

Event Description

A total of (b)(4) 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 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 - id (b)(6): a 71-year-old patient (bmi = 38.36) deep vein thrombosis: procedure related: 1 patient - that resolved before 3 months post-operative delirium: procedure related: 1 patient - that resolved before 3 months - id (b)(6): a 78-year-old patient (bmi = 25.25) syncope episode: procedure related: 1 patient - that resolved before 3 months - id (b)(6): a 64-year-old patient (bmi = 28.5) 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 - id (b)(6): a 42-year-old female patient (bmi = 32.91) nerve damage: procedure related: 2 patients - ongoing 1 patient - unknown status - id (b)(6): a 42-year-old patient (bmi = 40) 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 - id (b)(6): a 42-year-old female patient (bmi = 32.91) underwent reoperations due to: 2 patients - anterior neck hematoma evacuation - id (b)(6): a 48-year-old patient (bmi = 32.3) 1 patient - spine irrigation and debridement (hematoma removal) - id (b)(6): a 65-year-old patient (bmi = 22.96) 1 patient - cervical decompression (related to adjacent level disease) - id (b)(6): a 43-year-old patient (bmi = 22.37) underwent revision: revision plate/screw (resolved after surgery); vectra related id (b)(6): a 43-year-old patient (bmi = 31.2) additional products are captured on related complaints (b)(4).

• Brand Name: ACIS IMP-STERILE LORDOTIC/SM-8MM HT
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12041836
• MDR Text Key: 270486460
• Report Number: 2939274-2021-03145
• Device Sequence Number: 1
• Product Code: ODP
• UDI-Device Identifier: 10705034762609
• UDI-Public: (01)10705034762609
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 08.843.608S
• Device Catalogue Number: 08.843.608S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention