MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: MATRIXRIB PLATE/SCREWS; PLATE, FIXATION, BONE

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

Patient Problems Hematoma (1884); Pain (1994); Pleural Effusion (2010)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - constructs: matrixrib plate/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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

Event Description

This report is being filed after the review of the following journal article: toloza, e.Et al (2014), multilevel costovertebral reconstruction with the synthes matrixrib fixation system and vicryl mesh after radical chest wall resection for sarcoma: a case report, chest, vol.145 (3_meetingabstracts), page 34a (usa).This study presents a case report of a (b)(6)-year-old female patient who had a 15-cm right posterolateral chest wall rhabdomyosarcoma.She underwent radical right posterolateral chest wall resection, including ribs 4-9, en bloc resection of the right scapular tip and involved portions of latissimus, serratus, and rhomboid muscles.Resection of ribs 4-9 required disarticulation at their costovertebral joints.Chest wall reconstruction was performed by fixation of 6 synthes titanium rib plates (matrixrib fixation system) anterolaterally to the transected ribs and posteromedially to corresponding transverse processes.The patient was extubated immediately postoperatively but required bipap until perioperative pain was controlled.She required return to or on postoperative day (pod) #5 for video-assisted thoracoscopic evacuation of loculated right pleural effusion, doxycycline pleurodesis, revision of the myocutaneous flap posterior edge, evacuation of subcutaneous right flank hematoma, and revision of the stsg.She was extubated on pod#3, after which she became ambulatory with physical therapy.Her chest tubes and all but one submuscular drains were removed, and she was discharged from hospital to a rehabilitation facility on pod#18 from her initial chest wall resection and reconstruction.This report is for an unknown synthes matrixrib plate/screws constructs.This report is 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: MATRIXRIB PLATE/SCREWS
• 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
• MDR Report Key: 11761064
• MDR Text Key: 248530229
• Report Number: 2939274-2021-02188
• 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: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2021
• 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?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR