MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS; SCREW,FIXATION,BONE

Device Problem Unintended Movement (3026)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.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: zaveri, g.R.And ford, m.(2001), cervical spondylosis: the role of anterior instrumentation after decompression and fusion, journal of spinal disorders, vol.14 (1), pages 10-16 (canada).The aim of this study is to evaluate the use of instrumentation in anterior cervical decompression and fusion with respect to 1.The advantages, including more consistent fusion, reduced graft-related complications, and maintenance of intraoperative sagittal alignment correction; 2.Potential problems, including infection, hardware failure, and accelerated adjacent level disease; and 3.A comparison of these results with literature on the outcome of fusion without instrumentation.Between 1989 to 1997, a total of 47 patients (25 male and 22 female) with an age of 28 to 76 years (mean, 58.1 years) were included in the study.Surgery was performed using a titanium hollow screws and plate (synthes, paoli, pa, u.S.A.) in the first 9 cases, and the ao anterior cervical spine locking plates (synthes) in the other 38 patients.The following complications were reported as follows: 7 patients had evidence of accelerated changes at the level adjacent to the fusion mass on serial radiographs, as shown by reduced disk height, formation of osteophytes, or instability.Three of them were symptomatic, and the diagnosis of spinal cord¿root compression at that level was confirmed with a gadolinium enhanced mri.Although one patient responded to nonoperative treatment, the other two required another operation and, in fact, one of them experienced an ¿add-on syndrome¿ and required two more procedures at levels adjacent to previous fusions.1 patient had wound hematoma.2 patients had a prolonged postoperative dysphagia, but this gradually improved during a period of 6 months.2 patients had nonunion.One of them is a female patient who had a fractured plate and reported a feeling of movement in her neck and dysphagia.At repeated exploration, the plate was removed and the pseudoarthrosis was confirmed.The other patient experienced radiographic haloes around the screw.1 patient had 2 inferior screws that fractured at the plate-bone interphase.A solid fusion developed but with moderate local kyphosis.2 patients had loosened screws (4) as indicated by the development of haloes around the screws.One of these patients had 2 loose screws that backed out partially along with the plate.This report is for one (1) screw.This is report 4 of 8 for (b)(4).

• Brand Name: UNK - SCREWS
• Type of Device: SCREW,FIXATION,BONE
• 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: 8950194
• MDR Text Key: 156137636
• Report Number: 2939274-2019-60238
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• 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: 08/02/2019
• 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