MAUDE Adverse Event Report: ETHICON INC. MERSILENE TAPE UNKNOWN PRODUCT; INSTRUMENT, SURGICAL, DISPOSABLE

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

Patient Problems Wound Dehiscence (1154); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.Citation: j spinal cord med.August 2009; 32 (4): 389¿397.(b)(4).

Event Description

It was reported via journal article: title: "scapular stabilization in patients with spinal cord injury," authors: joshua m.Pahys, md; m.J.Mulcahey, otr/l, phd; david hutchinson, ms; randal r.Betz, md.Citation: j spinal cord med.August 2009; 32 (4): 389¿397.Severe scapular instability can be a considerable problem for people with high-level cervical spinal cord injury.The objectives of the study was to report the efficacy of a fusionless scapular stabilization procedure as a means to enhance function in a consecutive group of patients with high-level cervical spinal cord injury.Four people with spinal cord injury at c4¿c5 (2 male, 2 female; age range: 14 to 20 years old) underwent scapular stabilization via scapulothoracic fusion (n-2) or by tethering the scapula to the rib cage with mersilene tape (ethicon) as a fusionless stabilization (n-2).In patients 3 and 4, a fusionless scapulothoracic stabilization was performed.A one-third tubular ao plate was placed on the lateral border of the scapula, and a malleable retractor was held deep to the ribs to protect the pleura and chest cavity contents.Mersilene tape (ethicon) was then wrapped around each rib and passed through the scapula and one-third tubular plate.The scapula was reduced to approximately 15 degrees external rotation, and the mersilene tapes (ethicon) were tied down so as to allow some scapular motion with movement of the upper extremity.Reported complications included patient 4 with recurrent wound breakdown and subsequent loosening which required removal of the hardware.It was reported that the fusionless stabilization procedure aims to restore scapular stability while still allowing a small amount of scapular motion in an effort to recreate more normal shoulder kinematics.This scapular stabilization procedure is beneficial over formal scapulothoracic fusion in that there is no need to achieve an osseous fusion; therefore, post-operative immobilization time is drastically diminished and formal therapy can be initiated.The authors believed that fusionless scapular stabilization is a viable option for improving appearance, pain, and upper extremity function in patients with high-level tetraplegia and scapular instability.

• Brand Name: MERSILENE TAPE UNKNOWN PRODUCT
• Type of Device: INSTRUMENT, SURGICAL, DISPOSABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8048098
• MDR Text Key: 126447746
• Report Number: 2210968-2018-77029
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention