MAUDE Adverse Event Report: ETHICON INC. PDS PLATE UNKNOWN PRODUCT; POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE

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

Patient Problem Hematoma (1884)

Event Date 08/24/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events reported via 2210968-2022-08465.Citation: the journal of craniofacial surgery volume 00, number 00, month 2021 https://doi.Org/10.1097/scs.0000000000008179.

Event Description

Title: a new technique of open septal reduction using polydioxanone plates for nasoseptal fracture: three- dimensional volumetric analysis.This retrospective study aims to compare a new technique for open septal reduction using a polydioxanone (pds) plate with closed reduction (cr) for nasoseptal fracture.From june 2017 to december 2019, we reviewed 19 consecutive patients with nasoseptal fractures who received surgery.The patients were divided into 2 groups: a cr group , with 7 males and 2 females, ( closed reduction (cr) group) and a polydioxanone (pds) plate group with 8 males and 2 females (pds group).The mean ages of the closed reduction (cr) group and polydioxanone (pds) plate group were 41 and 43.3 years, respectively.The procedure was performed with general anesthesia in all patients.First, cr was performed to correct nasal bone fracture using a blade handle and walsham forceps.In the pds group, the 0.25-mm-thick pds plate (pds flexible plate; ethicon, somerville, nj) was cut to about 2 cm height with scissors.In the last 7 patients, we made holes in the polydioxanone (pds) plate using a 1-mm punch biopsy device.The polydioxanone (pds) plate was placed beside the fractured septal cartilage horizontally above the vomerine suture.The polydioxanone (pds) plate was not inserted diagonally close to the dorsal septum to avoid narrowing of the internal valve due to the thickness of the polydioxanone (pds) plate.After insertion of the polydioxanone (pds) plate , it was fixed with 3-0 chromic mattress sutures through the full layers of the septum.The incision was closed with 4-0 chromic suture.Reported complications included: (n=1) septal hematoma was noted 3 months after surgery.Septal hematoma was resolved by needle aspiration and nasal packing.(n=1) figure 7.Clinical presentation 2.A 59-year-old woman who experienced exposure of a polydioxanone (pds) plate after it was used for open septal reduction.(a) preoperative photography revealed nasal deviation to the right side and loss of dorsal height.(b) although part of the polydioxanone (pds) plate was exposed and removed, as presented in figure 3, the nasal deviation and dorsal height were successfully recovered by cr of the nasal bone and open septal reduction using the polydioxanone (pds) plate.(c) there were septal deviation and discrepancy between the 2 sides on preoperative 3d volumetry.(d) the septal deviation was corrected after surgery.3d, three-dimensional; cr, closed reduction; pds, polydioxanone it was concluded ,that polydioxanone plates are effective stenting materials to reinforce the fractured septum in open septal reduction.When open septal reduction is performed using a polydioxanone (pds) plate, it is important to prevent complications when the polydioxanone (pds) plate is inserted to the concave side of septal deviation and is used with added perforations.In our experience, polydioxanone (pds) plate potentially present a new concept of open septal reduction in terms of septal reinforcement compared with the subtractive manner of open septal reduction.

• Brand Name: PDS PLATE UNKNOWN PRODUCT
• Type of Device: POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15614460
• MDR Text Key: 301822790
• Report Number: 2210968-2022-08464
• Device Sequence Number: 1
• Product Code: NHB
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K092590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• 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: 10/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention