MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PLATES: 2.0 MM RECONSTRUCTION PLATE; PLATE, FIXATION ,BONE

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

Patient Problem Dysphagia/ Odynophagia (1815)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Pma/510k: this report is for an unk: plates: reconstruction/unknown lot.Part and lot numbers are unknown; udi 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.The product was not returned.Based on the information available, it has been determined that no corrective and 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.

Event Description

This report is being filed after the review of the following journal article: buckley m., et al (2021) double mandibular osteotomy for access to high-carotid pathology, ann vasc surg volume 70: 202¿212 (usa).This retrospective study aims to report our outcomes utilizing the dmo technique developed in our academic medical center for exposure of high-carotid artery pathology including carotid stenosis, carotid body tumors, and carotid aneurysms.From 2011 to 2019, fifteen patients (10 women and 5 men) with age range of 27-76 years with a mean of 60.7 years underwent 16 procedures utilizing dmo for exposure and repair of skull-based carotid artery lesions for treatment of carotid atherosclerotic disease, carotid body tumors, and extracranial carotid aneurysms at the university of tennessee medical center in knoxville were evaluated.The planned sub condylar osteotomy (proximal) superior to the lingula and the vertical osteotomy (distal) anterior to the mental foramen was delineated.A synthes (depuy synthes, west chester, pa) 2.0 mm reconstruction bone plate was then adapted and secured to span the osteotomies.The plate was removed after placement in preparation for the osteotomies.A panoramic radiograph was obtained before discharge from the hospital, and repeat panoramic radiographs were obtained at 3 months, 6 months, 12 months, and 24 months postoperatively to investigate the healing of the osteotomy sites and stability of bone plates.The following complications were reported: patient no 1 developed dysphagia requiring enteral feeding via peg tube due to sacrifice of cranial nerve ix and x.Attributed to the dmo procedure itself.Patient no 9 developed dysphagia requiring enteral feeding via peg tube.Patient no 10 developed dysphagia requiring enteral feeding via peg tube / bilateral postoperative strokes with recovery.Patient no 11 developed dysphagia requiring enteral feeding via peg tube.Patient no 13 developed dysphagia requiring enteral feeding via peg tube.Patient 7 developed chronic osteomyelitis of the mandibular segment requiring operative debridement and intravenous antibiotic therapy with subsequent distal segment hardware removal.This was the only patient to demonstrate oral exposure of an exposed screw thread in the distal segment that required secondary removal after earlier bone plate removal in this segment.Attributed to the dmo procedure itself.One patient with contralateral carotid occlusion suffered a watershed cortical infarct in the contralateral hemisphere due to inability to place a carotid shunt.This patient ultimately recovered with no chronic neurologic sequelae.Patient no.5 had significant postoperative malocclusion.Attributed to the dmo procedure itself.Patient no.8 had significant postoperative malocclusion.Attributed to the dmo procedure itself.This report is for an unknown synthes 2.0 mm reconstruction bone plate.This report is for (1)unk - plates: reconstruction.This report is 7 of 13 for (b)(4).

Event Description

This report is for unknown 2.0mm reconstruction plates.

• Brand Name: UNK - PLATES: 2.0 MM RECONSTRUCTION PLATE
• 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: 12489108
• MDR Text Key: 273078805
• Report Number: 2939274-2021-05508
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention