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U.S. Department of Health and Human Services

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

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
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.
 
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Brand NameUNK - SCREWS
Type of DeviceTHORACOLUMBOSACRAL 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 Key9144897
MDR Text Key165992191
Report Number2939274-2019-61099
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received10/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/02/2019 Patient Sequence Number: 1
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