MAUDE Adverse Event Report: ETHICON INC. PDS FOIL VIO 0.15X40X30MM; POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE

Catalog Number ZX7

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

Patient Problems Eye Injury (1845); Visual Disturbances (2140); Insufficient Information (4580)

Event Date 08/27/2022

Event Type  Injury  

Event Description

Title: prospective evaluation of two wall orbital fractures involving the medial orbital wall: psi reconstruction versus pds repair¿worth the effort? this prospective study aimed to evaluate the outcome of full orbital reconstruction using psis compared to only orbital floor repair using pds (bioresorbable polydioxanone) foils leaving the medial orbital wall untouched in traumatic two-wall orbital fractures.A total of 68 patients (50 male and 18 female) who suffered from traumatic orbital fracture, with a two-wall orbital fracture involving both the orbital floor and the medial wall and were treated at the university hospital of düsseldorf between 2017 and 2019 were included.Patients were treated either with a psi [kls-martin (tuttlingen, germany) or synthes (umkirch, germany), n = 35] or a pds foil (0.15 x 30 x 40 mm, orbital cut, perforated; n = 33).The average age at the time of trauma was 45.6 years (sd = 20.54) for the psi group and 43.0 years (sd = 19.95) for the pds group, respectively.Reported complications include lasting diplopia (n=3); globe malposition including enophthalmos, exophthalmos, hypoglobe and hyperglobe (n=23); sensibility disorder including hypoesthesia, hyperesthesia and paresthesia (n=2).In conclusion, the results of this study suggest that complex orbital fractures can be reconstructed at an even higher degree of accuracy with selective laser-melted psis than pds foils.In order to achieve a true to original reconstruction of the bony orbit, surgical treatment of the medial orbital wall can be advocated for in the long term depending on the indication.

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: j.Pers.Med.2022, 12 (1389):1-14.Https://doi.Org/10.3390/jpm12091389.

• Brand Name: PDS FOIL VIO 0.15X40X30MM
• 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: 15614536
• MDR Text Key: 301821029
• Report Number: 2210968-2022-08466
• Device Sequence Number: 1
• Product Code: NHB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Device Catalogue Number: ZX7
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2022
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention