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

Device Problem Migration (4003)

Patient Problems Dyspnea (1816); Non-union Bone Fracture (2369); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown cervical spine 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: m.L.Swank, g.L.Lowery, a.L.Bhat and r.F.Mcdonough (1997), anterior cervical allograft arthrodesis and instrumentation: multilevel interbody grafting or strut graft reconstruction, european spine journal vol.6(2), pages 138-143 (usa).The aim of this retrospective study was to compare fusion success and clinical outcome between multilevel smith-robinson interbody grafting and tricortical iliac strut graft reconstruction, both supplemented with anterior instrumentation in the cervical spine.A total of 64 patients (37 males and 27 females) with a mean age of 51 years (ranges, 30-78 years) were included in the study.Were 25 patients used cervical spine locking plate.These patients had cervical spondylosis underwent either a two-level or three-level discectomy.Both groups were reconstructed using allograft tricortical iliac crest bone and stabilized by anterior cervical plating.The mean duration of follow-up was 39 months.The article did not specify which of the devices were being used to capture the following complications: 24 patients had a symptomatic pseudarthrosis.10% nonunion occurred in the corpectomy group.When three discs were removed, the incidence of nonunion was 44% for corpectomy group.There was an average reduction of 71% and 78% in axial and appendicular pain.7 patients with a solid fusion had a slight increase in their subjective axial pain scores.2 patients experienced an increase in appendicular pain.17 patients had revision surgery, either for nonunion (n = 16) or for adjacent disc degeneration (n = 1).2 patients with ossification of their posterior longitudinal ligaments had a dural leak at the time of surgery that was surgically repaired without any complications and treated with a lumbar csf diversion drain.1 patient had a nonfatal pulmonary embolus that was treated with anticoagulant drugs.1 patient developed hoarseness and dysphagia that resolved within 6 weeks.Another patient developed postoperative dysphagia that also resolved within 6 weeks.1 patient had transient right sided deltoid weakness that improved gradually over 10 weeks.29 patients had secondary procedures.4 patients required further surgery after degeneration of levels adjacent to a solid fusion.1 patient had an additional surgery for continued radicular symptoms.3 patients had significant hardware failure that independently necessitated hardware revision and had a pseudoarthrosis.1 patient had a revision after early hardware failure.2 cases broken plate for clsp.2 cases loose plate for clsp.Lateral flexion radiograph 35 months after surgery showing a broken inferior fenestrated screw and loose superior lock screw, but the patient has the appearance of a solid fusion, and he had no symptoms.The symptoms returned after 6 months, and an anterior revision surgery was performed.Figure 3 a second patient was noted to have one broken inferior screw and one loose inferior screw that required removal.6 cases broken screws for clsp.3 cases loose screws for clsp.1 patient underwent emergency intubation 2 days postoperatively for respiratory difficulty with plate dislodgement of 2 mm.This is report 6 of 6 for (b)(4).This report is for an unknown synthes cervical spine 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: 9144897
• MDR Text Key: 165992191
• Report Number: 2939274-2019-61099
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• 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: 09/06/2019
• 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