MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES: MATRIXRIB; PLATE, FIXATION ,BONE

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

Patient Problems Calcium Deposits/Calcification (1758); Neuropathy (1983); Pain (1994); Discomfort (2330); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown matrixrib plate/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between (b)(6) 2015 and (b)(6) 2018.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.(b)(4).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: caragounis, e.C., olsénb, m.F., granhed, h., and norrlund, r.R.(2019), ct-lung volume estimates in trauma patients undergoing stabilizing surgery for flail chest, injury, vol.50, pages 101-108 (sweden).The aim of this study, therefore, was to estimate and compare lung volumes in trauma patients with flail chest undergoing stabilizing surgery using pre- and post-operative ct images, and to correlate these findings to post-operative lung function tests.Between october 2015 and january 2018, a total of 37 patients who had undergone stabilizing surgery for flail chest at least 6 months previously were included in the study.There were 26 males and 11 females with a median age of 62 (19¿90) years.The implants used were matrixrib fixation system (depuy synthes, west chester, usa) consisting of preshaped angular locked plates and intramedullary splints.Median follow-up time was 3.9 (0.5¿5.6) years post trauma.A clinical follow-up was done 6 months post-operatively at the earliest.The following complications were reported as follows: 2 patients complained of pain at rest and when breathing.6 patients complained of breathlessness.14 patients complained of local discomfort.10 patients complained of decreased local sensation.3 patients used analgesia at follow-up.Post-operative lung volumes were higher than pre-operative lung volumes in the four patients who were intubated at initial ct.1 patient showed signs of lung fibrosis and usual interstitial pneumonia.11 patients had heterotropic ossification with rib synostosis.1 patient had an implant dysfunction with 2 loose screws.This report is for an unknown synthes matrixrib fixation system.This report is for one (1) unknown matrixrib plate.This is report 1 of 4 for (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.A copy of the literature article is being submitted with this medwatch.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.(b)(4).

• Brand Name: UNK - PLATES: MATRIXRIB
• Type of Device: PLATE, FIXATION ,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10029137
• MDR Text Key: 194512476
• Report Number: 8030965-2020-03326
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• 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: 04/28/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention