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 Cerebrospinal Fluid Leakage (1772)

Event Date 01/01/2024

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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.As no contact information has been provided, no follow up can or will be performed at this time.If further details are received at a later date a supplemental medwatch will be sent.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.H6 component code: g07002 ¿ device not returned.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: j neurol surg b skull base.2024.

Event Description

Title: utilization of polydioxanone plate for endoscopic anterior skull base repair: operative technique and long-term cohort outcomes.The purpose of this study is to report the technical procedure and our experience using a polydioxanone suture plate (pds plate, ethicon) with dural substitute as part of a fully resorbable gasket seal technique to repair anterior skull base defects.Between january 2014 and july 2022, 155 patients undergoing anterior skull base reconstruction utilizing the resorbable gasket seal technique were included in the study.Reported complications included postoperative cerebrospinal fluid leaks requiring reoperation (n=9).In conclusion, pds plate reconstruction confers several advantages and can be used in a diverse set of operative scenarios in conjunction with other reconstruction options.There appeared to be an associated learning curve as surgeons at our center gained experience with this new technique.Our findings show that the pds plate reconstruction is safe and effective in repairing the skull base.

• 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: 18893445
• MDR Text Key: 337524828
• Report Number: 2210968-2024-02967
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• 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: 02/26/2024
• 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