MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREW/ROD CONSTRUCT ACCESSORIES; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

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

Patient Problems Pain (1994); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screw/rod construct accessories/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: 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 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: id 2: a 42-year-old 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 45-year-old 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 50-year-old patient (bmi = 28.29) experienced neck and shoulder pain; shoulder and neck pain continuing.Id 5: a 51-year-old 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 76-year-old patient (bmi = 25.5) experienced pain in both shoulders; pain swallowing.Id 10: a 43-year-old 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 78-year-old patient (bmi = 25.25) experienced postop delirium prior to discharge; return of back pain and jerking of leg/ feet.Id 13: a 75-year-old 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 55-year-old patient (bmi = 42) experienced difficulty swallowing at 6 week postop.Id 19: a 64-year-old patient (bmi = 28.5) had syncope episode prior to discharge.Id 21: a 55-year-old 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 45-year-old patient (bmi = 38.36) had difficulty swallowing at 6 week postop; had continued neck and right arm pain.Id 24: a 44-year-old patient (bmi = 33.1) had difficulty swallowing at 6 week postop; neck and right arm pain; cervical pain with right arm pain that is chronic and severe.Id 31: a 57-year-old patient (bmi = 27.1) had moderate neck stiffness at 3 month postop.Id 33: a 65-year-old patient (bmi = 22.96) 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.Id 34: a 42-year-old patient (bmi = 40) had an ed visit on 9-2-2018 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 54-year-old patient (bmi = 41.5) had neck pain post surgical flare up; patient fell in tub 3-9-17 and hit head/neck.Id 37: a 48-year-old patient (bmi = 28.1) had difficulty swallowing prior to discharge.Id 40: a 37-year-old patient (bmi = 30.3) had difficulty swallowing at 6 week postop.Id 41: a 66-year-old patient (bmi = 28.18) had difficulty swallowing prior to discharge; at 6 week postop had left arm pain at 2 week follow up, resolving.Id 43: a 52-year-old patient (bmi = 37.6) had pain and difficulty swallowing prior to discharge; had cervical pain with radiating pain down right arm.Id 44: a 48-year-old patient (bmi = 32.3) had anterior neck hematoma evacuation.Id 45: a 39-year-old patient (bmi = 33.08) 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; id 47: a 41-year-old patient (bmi = 27.36) had difficulty swallowing at 6 week postop which continued to 12 month postop.Id 52: a 46-year-old patient (bmi = 39.9) had pain and difficulty swallowing prior to discharge; at 3month postop had cervical stiffness.Id 49: a 63-year-old patient (bmi = 31.22) 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.Id 53: a 43-year-old patient (bmi = 22.37) had debilitating neck and arm pain; underwent cervical decompression.Id 54: a 43-year-old patient (bmi = 31.2) 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).Id 55: a 57-year-old patient (bmi = 28.1) had difficulty swallowing prior to discharge id 56: a 56-year-old patient (bmi = 33.4) had difficulty swallowing prior to discharge; at 6week postop had continued difficulty swallowing; id 58: a 64-year-old patient (bmi = 58.46) had difficulty swallowing prior to discharge; at 6 week postop had previous trouble swallowing, pain in both shoulders.Id 59: in a 53-year-old 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 47-year-old patient (bmi = 34.62) had fall back in june; continued neck and shoulder pain, tingling/ numbness in arms at 12 month postop.Id 63: a 49-year-old 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 50-year-old 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 43-year-old patient (bmi = 37.2) had shoulder pain at 6 week postop; at 6month postop had continued worsening neck pain; at 12month postop had cervical and left side pain.Id 67: a 38-year-old 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 65-year-old patient (bmi = 32.44) had difficulty swallowing prior to discharge id 70: a 71-year-old 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 55-year-old patient (bmi = 34.7) 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.Id 77: a 45-year-old patient (bmi = 53.11) had constant ache posterior neck, head, and shoulders at 3month postop.Id 78: a 73-year-old patient (bmi = 28.7) 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 id 70: 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 11: a 78-year-old patient (bmi = 25.25).Syncope episode: procedure related: 1 patient - that resolved before 3 months.Id 19: 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 2: a 42-year-old female patient (bmi = 32.91).Nerve damage: procedure related: 2 patients - ongoing.1 patient - unknown status.Id 34: 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 2: a 42-year-old female patient (bmi = 32.91).Underwent reoperations due to: 2 patients - anterior neck hematoma evacuation.Id 44: a 48-year-old patient (bmi = 32.3).1 patient - spine irrigation and debridement (hematoma removal).Id 33: a 65-year-old patient (bmi = 22.96).1 patient - cervical decompression (related to adjacent level disease).Id 53: a 43-year-old patient (bmi = 22.37).Underwent revision: revision plate/screw (resolved after surgery); vectra related.Id 54: a 43-year-old patient (bmi = 31.2).This is for depuy synthes acis cage, vectra, and pedicle screw/rod construct.(b)(4).

• Brand Name: UNK - SCREW/ROD CONSTRUCT ACCESSORIES
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14573699
• MDR Text Key: 294797635
• Report Number: 2939274-2022-02000
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2022
• 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