MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: MATRIXRIB PLATE/SCREWS; PLATE,FIXATION,BONE

Catalog Number UNK - CONSTRUCTS: MATRIXRIB PL

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

Patient Problem Pain (1994)

Event Date 07/26/2020

Event Type  Injury  

Manufacturer Narrative

Pma/510k: this report is for an unknown matrix rib system/unknown lot.Part and lot numbers are unknown; udi number is unknown.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: niemann m, et al.(2020), retrospective analysis of the clinical outcome in a matched case-control cohort of polytrauma patients following an osteosynthetic flail chest stabilization, journal of clinical medicine, volume 9, pages 1-9, (germany).This study intends to investigate the clinical outcome of polytrauma patients with the diagnosis of a flail chest who received an osteosynthetic stabilization for that compared to the same group of patients without an operative treatment.Between january 2012 and december 2019, 70 polytrauma patients with a flail chest were included in the study.There were 17 females, 53 males with a mean age of 50.69+/-16.18 years.Of these patients, 59 underwent conservative treatment.Meanwhile, 11 patients (all males) underwent operative treatment and were treated using the unknown synthes matrixrib system.Complications were reported as follows: unknown patients had pain and had oral pain medications upon discharge.A 52-year-old male patient died of pulmonary embolism at day 18 after the primary hospital admission.6 male patients had clinical and radiographic diagnosis of pneumonia and were treated with antibiotic.This report is for the unknown synthes matrixrib system.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: MATRIXRIB PLATE/SCREWS
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12497552
• MDR Text Key: 273083926
• Report Number: 8030965-2021-07869
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - CONSTRUCTS: MATRIXRIB PL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2021
• 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
• Patient Outcome(s): Required Intervention