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 Problems Abscess (1690); Cellulitis (1768); Hematoma (1884); Hemorrhage/Bleeding (1888); Pocket Erosion (2013); Seroma (2069); Deformity/ Disfigurement (2360); Obstruction/Occlusion (2422); Insufficient Information (4580)

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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? 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.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: facial plastic surgery & aesthetic medicine volume 0, number 0, 2022 ª american academy of facial plastic and reconstructive surgery, inc.Https://doi.Org/10.1089/fpsam.2021.0421.

Event Description

Title: septal perforation repair using a temporoparietal fascia and polydioxanone plate construct: a multi-institutional analysis.This retrospective study aims to compare rates of success with temporoparietal fascia (tpf)¿polydioxanone (pds) plate (tpf¿pds) interposition grafting for nasal septal perforations (nsps) repair among fellowship-trained facial plastic surgeons at geographically disparate institutions, utilizing both lasting mucosal closure and improvement in nasal obstruction symptomatic evaluation (nose) score as primary outcomes.From january 1, 2015 to october 31, 2021, patients undergoing nasal septal perforations (nsps) repair using temporoparietal fascia (tpf)¿polydioxanone (pds) plate (tpf¿pds) interposition grafting were reviewed.Sixty-two patients were included from seven different institutions across the united states, including 29 from the south , 16 from the midwest, 11 from the east coast , and 6 from the mountain west.Participants consisted of 39 females (and 21 males.The mean age at presentation was 41.5, ranging from 18 to 70 years.All patients underwent septal perforation repair with temporoparietal fascia (tpf)¿polydioxanone (pds) plate (tpf¿pds) interposition grafting through open septoplasty approach.17 this was done in combination with other nasal procedures in 52 patients, most commonly nasal framework surgery (n = 43).A temporoparietal fascia (tpf) graft averaging 17.4 cm2 (sd, 9.6) was harvested in the standard manner and secured across a 0.15mm polydioxanone (pds) plate for implantation in all cases.Stents were placed in all patients, as either 1.02mm silastic sheeting (n = 51), doyle splints (n = 33), or both (n = 23).The median (range) postoperative follow-up duration was 196 (70¿1119) days.Reported complications included: twenty complications were experienced among 17 patients (postoperatively, ranging from minor (scalp seroma [n = 5], delayed mucosalization [n = 4], and nasal cellulitis [n = 4]) to major (recurrence [n = 2], extrusion [n = 1], septal hematoma [n = 1] or abscess [n = 1]).(n=2) stable recurrent perforations chosen not to be reoperated on.Persistent symptoms: (n=18) crusting, (n=8) obstruction, (n=2) epistaxis, (n=1) external deformity.It was concluded ,that temporoparietal fascia (tpf)¿polydioxanone (pds) plate (tpf¿pds) interposition grafting is highly effective for nasal septal perforations (nsps) repair in a wide variety of settings, and nasal obstruction symptomatic evaluation (nose) scores correspond well with patient-reported outcomes.

• 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: 15614313
• MDR Text Key: 301821812
• Report Number: 2210968-2022-08463
• Device Sequence Number: 1
• Product Code: NHB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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