MAUDE Adverse Event Report: SYNTHES GMBH UNK - RESORBABLE IMPLANTS; PLATE, BONE

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

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - rapidsorb ips implants/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.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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: qi, q.Et al.(2021), deployment of a bioabsorbable plate as the rigid buttress for skull base repair after endoscopic pituitary surgery, gland surgery, vol.10, no.3, pages 1010 - 1017 (china).This study aimed to describe the use of a biodegradable plate (polymax rapid) in skull base repair of endoscopic endonasal pituitary surgery and to investigate the clinical outcome and safety of this novel method.Between january 2019 and january 2020, 22 patients with pituitary adenomas underwent endoscopic skull base repair using a polymax rapid plate.There were 10 males and 12 females with an average age of 51.9 years.The patients were also followed up by appointed clinicians to do routine radiological examinations at 3, 6, and 12 months after surgery.The following complications were reported as follows: no.1: a (b)(6) year-old female patient had a grade 1 csf leak.No.4: a (b)(6) year-old male patient had a grade 1 csf leak.No.10: a (b)(6) year-old female patient had a grade 1 csf leak.No.14: a (b)(6) year-old male patient had a grade 1 csf leak.No.19: a (b)(6) year-old female patient had a grade 1 csf leak.No.20: a (b)(6) year-old female patient had a grade 1 csf leak.3 patients had nasal stiffness.2 patients had tolerable headaches.This report is for an unknown synthes biodegradable plate (polymax rapid).This report is for (1) unk - rapidsorb ips implants.This is report 3 of 7 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.

• Brand Name: UNK - RESORBABLE IMPLANTS
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11962543
• MDR Text Key: 267226087
• Report Number: 8030965-2021-04711
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1