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

Catalog Number UNK - PLATES: MATRIXWAVE

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

Patient Problems Weakness (2145); Ptosis (2620)

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unknown plates: matrixwave/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.(b)(4) without a lot number, the device history records review could not be completed as no product was received.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive 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: kantar r., et al (2019) facial transplantation for an irreparable central and lower face injury: a modernizedapproach to a classic challenge, plastic and reconstructive surgery, volume 144(2), pages 264e¿283e(usa) doi:10.1097/prs.0000000000005885.This study presents a case report of a male patient to report the successful completion of a partial face and double-jaw transplant who previously sustained ballistic facial trauma.A case of a (b)(6)-year-old man who sustained a ballistic facial injury in (b)(6) 2016 was a recipient.He underwent multiple procedures for stabilization acutely following injury, including maxillary, mandibular, zygomatic, and right orbital floor open reduction and internal fixation, in addition to the bilateral anterolateral thigh and supraclavicular flaps to the central and lower face.He was otherwise healthy with tissue deficits resulting in lip incompetence, speech and feeding difficulties, exposed hardware, and visual alterations.In preparation for facial transplantation and to improve functional status, the patient underwent percutaneous gastrostomy placement, open tracheostomy, hardware removal, bilateral nasoorbitoethmoid osteotomies, medial canthal tendon repositioning, and bilateral orbital floor reconstruction with alloplastic titanium implants in (b)(6) 2017.Recipient facial preparation was performed all remaining hardware was removed.Allograft procurement was performed by most teams with the donor.Creation of a mask that closely rigid fixation of the allograft to the recipient was completed at the zygomatic bodies using 0.7-mm miniplates and bilateral mandibular fixation was performed using bicortical 1.85-mm positional lag screws (matrixorthognathic plating system; depuy synthes cmf, (b)(4)).The intraoral palatal, buccal, and floor-of mouth mucosal tissues were approximated to reestablish oral competence.Special attention was given to repair the mylohyoid and superior strap muscles.The recipient¿s new dentition was subsequently placed in a prefabricated, three-dimensionally¿printed dental splint, and occlusion was secured using previously placed, maxillary and mandibular skeletal anchorage screws (matrixwave mmf system; depuy synthes cmf).On postoperative day 1, the patient underwent evacuation of a right neck hematoma, followed by hyoid and genioglossus suspension to the inferior border of the mandible and palatal wound débridement and reapproximation as described in on postoperative day 11.Persistent bilateral parotid sialoceles necessitated placement of bilateral stensen duct stents on postoperative day 17, leading to complete resolution.On a postoperative day 108, the patient underwent bilateral medial canthoplasties for bilateral telecanthus, lower eyelids tissue rearrangement for bilateral lower eyelid retraction and cheek ptosis, and open reduction and internal fixation of left mandibular nonunion using titanium plate and monocortical screws.On a postoperative day 151, the tracheostomy tube was removed with the closure of the tracheal stoma, muscle flap coverage of the tracheal stoma repair, and excision of hypertrophic neck scars.On a postoperative day 249, left lower eyelid tissue rearrangement and medial canthoplasty were performed for eyelid malposition and mild telecanthus, and floor-of-mouth z-play was performed for tethering of the tongue tip and floor of the mouth.The palate and floor of mouth demonstrated adequate healing on a postoperative day 284.At the most recent follow-up, the patient demonstrated satisfactory speech intelligibility, and his entire nutritional intake was by mouth.He exhibited difficulty with forming bilabial words and plosives because of incomplete lip puckering.Bilateral facial muscle mild to moderate weakness was noted with smiling and snarling, more on the left side, and eyelid closure was intact bilaterally.Sensation to light touch was intact bilaterally.The tracheostomy was removed on postoperative day 151, and he had no difficulty breathing.He was able to perform activities of daily living independently.This report is for an unknown synthes matrixorthognathic plating system and unknown synthes matrixwave mmf system.This report is 3 of 4 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.

• Brand Name: UNK - PLATES: MATRIXWAVE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9632599
• MDR Text Key: 189598396
• Report Number: 2939274-2020-00399
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,other
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - PLATES: MATRIXWAVE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR