MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; PLATE, FIXATION, BONE

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

Patient Problems Dysphagia/ Odynophagia (1815); Weakness (2145)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plate/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Investigation summary 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: mayr, m.T.Et al.(2002), cervical spinal stenosis: outcome after anterior corpectomy, allograft reconstruction, and instrumentation, journal of neurosurgery, vol.96(1), pages 10-16 (usa).To assess clinical and radiographic outcomes, we retrospectively reviewed a series of 261 patients, treated over a 6-year period, in whom a single surgeon (r.W.H.) performed anterior cervical corpectomy, placement of allograft fibular strut, and anterior plate fixation.Between october 1989 and june 1995, 261 patients with a mean age of 47.4 years (range 15-72 years) were included in the study.Out of 261 patients, 78 patients were treated with an unknown synthes cervical spine locking plate.The mean follow-up period was 25.7 months (range 24-47 months).The following complications were reported as follows: 2 patients noted no improvement in their myelopathy over the follow-up period.2 patients had transient unilateral upper-extremity weakness.35 patients had transient dysphagia.7 patients had permanent dysphagia.35 patients had transient hoarseness.2 patients had permanent hoarseness.1 patient required an injection of teflon for a recurrent laryngeal nerve palsy.The second patient suffered a superior laryngeal nerve palsy.14 asymptomatic patients had hardware failure.12 patients had screw fractures and 2 patients had screw pullouts.3 patients had broken screws.1 of 2 female patients with osteoporosis underwent two-level corpectomies and stabilization.The upper screws pulled away from the bone, but solid fusion eventually developed.She didn't experience dysphagia.2 of 2 female patients with osteoporosis underwent two-level corpectomies and stabilization.The upper screws pulled away from the bone, but solid fusion eventually developed.She didn't experience dysphagia.These impacted products capture the reported no improvement of myelopathy, transient unilateral upper-extremity weakness, transient and permanent dysphagia, transient and permanent hoarseness.This is for an unknown synthes cervical spine locking plate.This report is 1 of 5 for (b)(4).

• Type of Device: PLATE, 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: 8937696
• MDR Text Key: 156339806
• Report Number: 2939274-2019-60134
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2019
• 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