MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problem Migration (4003)

Patient Problems Dysphagia/ Odynophagia (1815); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown cervical screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: fountas, k.N.Et al.(2007), anterior cervical discectomy and fusion associated complications, spine, vol.32, number 21, pages 2310-2317 (usa); doi: 10.1097/brs.0b013e318154c57e.The goal of our current study is to raise awareness on complications associated with anterior cervical discectomy and fusion (acdf) and their early detection and proper management.A total of 1015 patients (549 males and 446 females) with a mean age of 5603 years (range 28 to 75 years) were treated with a cslp low-profile, restricted backout, constrained anterior plate (synthes, inc., west chester, pa).The follow-up time ranged between 18 and 36 months (median, 24 months; mean, 26.4 months), while all participants were followed for at least 12 months.The following complications were reported as follows: 1 patient had an esophageal perforation that was not intraoperatively detected.The patient complained of some mild dysphagia (mainly to solid food) on the first postoperative day.The obtained cervical spine radiographs and ct scan revealed no hematomas or any soft tissue swelling at the operative site.On the second postoperative day, the patient became febrile and was empirically started on antibiotics.An obtained chest ct scan intensified the suspicion of mediastinitis and an endoscopic exploration of the mediastinum was emergently performed by a cardiothoracic surgeon, which revealed an esophageal tear of the upper esophagus while copious amounts of pus and food remnants were present in the mediastinum.The esophageal tear was repaired and the surgical wound was thoroughly irrigated with antibiotic irrigation.After surgery, the patient remained intubated and was admitted to the neurointensive care unit, while she was covered with broadspectrum antibiotics.Despite aggressive management, she died 10 days after the initial procedure.56 patients didn't have radiographic fusion at 12 months after surgery.97 patients complained of mild to moderate postoperative dysphagia (defined as pain with swallowing, difficulty in swallowing, coughing or chocking with swallowing, new-onset heartburn, regurgitation of old food, feeling of throat blockage, and/or frequent throat clearing).The observed dysphagic symptoms were not severe in any of these patients and were more prominent in regard to solid foods than liquids.In the vast majority of these patients (92 of 97) their complaints vanished within 2 to 7 days after surgery.In the remaining (5 of 97) patients, their dysphagia slowly improved over a 2- to 4-week period and finally disappeared with no further consequences.57 patients developed clinically evident postoperative soft tissue hematoma (presented with severe dysphagia, respiratory difficulties, and/or painful neck swelling).In 24 of these patients, an emergent surgical evacuation was required; whereas in the remaining 33 patients, conservative management with close observation was used.All these patients recovered with no further consequences.32 patients, postoperative unilateral recurrent laryngeal nerve (rln) palsy was clinically evident (postoperative wet quality of voice and/or new postoperative hoarseness).In all these cases, the clinical diagnosis was confirmed by using indirect laryngoscopy.All patients were conservatively treated and spontaneous resolution of their symptomatology was observed, in all patients, within a 12-week period.5 patients had a development of a cerebrospinal fluid leakage due to a dural perforation.In 4 of these cases, dural opening was accidental; whereas in 1 case, the dura was intentionally opened for removing a large intradural disc fragment.All these cases were managed with the insertion of a closed-loop lumbar drain system 14 and meticulous water-tight wound closure.All patients recovered with no further consequences.3 patients had accidental esophageal perforation occurred; and in 1 of these patients, the outcome was fatal (this is pertaining to the patient who was mentioned above who died).In both cases, the opening of the esophagus was intraoperatively recognized and surgical repair of the esophageal tear was performed by a cardiothoracic surgeon.Both patients maintained regimens with no oral intake for 6 days after surgery and recovered with no other consequences.Their follow-up revealed no dysphagia or any other difficulties.2 patients had worsening of preexisting myelopathy.It was revealed that a cord contusion at the level of the surgical intervention, which was apparently the result of an overzealous surgical maneuver.Both patients were placed on intensive physical therapy and their neurologic examination was gradually improved within 6 weeks.Both patients returned to their preoperative functional level 12 weeks after the procedure and had no neurologic deficits or myelopathic signs at their 12-month follow-up evaluation.1 patient had temporary unilateral horner syndrome developed after surgery, ipsilaterally to the surgical site; this was spontaneously resolved within 6 weeks.1 patient after surgery developed a superficial surgical wound infection, which did not require surgical wound exploration and was successfully managed with oral antibiotics.1 patient had delayed back-out of implanted screws occurred, approximately 16 months after the procedure.It has to be emphasized, however, that the initial position of the implanted upper screws was improper (1 screw was partially threaded in the upper vertebral body while the other one was inserted in a 30° angle).The position was considered adequate by the performing surgeon at that point.The patient presented with delayed acute-onset severe dysphagia (more prominent in solid food than liquids) 16 months after undergoing an uneventful c5¿c6 acdf with autologous bone graft and anterior cervical plate.The obtained radiographic studies revealed 1 backed-out screw and a second that had dislodged to the right lower abdominal quadrant (apparently after eroding the posterior wall of esophagus and entering into the digestive canal).The patient¿s neck was re-explored through his previous skin incision and the previously implanted instrumentation was safely removed, revealing a solid osseous fusion at this level.Surprisingly, endoscopy revealed no esophageal perforations or any esophageal strictures.The dislodged screw in the abdomen was endoscopically removed, and the patient was placed on antibiotics.His dysphagia slowly improved, and no other difficulties occurred.This is report 3 of 4 for (b)(4).This report is for cervical screws.

• Brand Name: UNK - SCREWS
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9076500
• MDR Text Key: 161976081
• Report Number: 2939274-2019-60632
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2019
• 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