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 Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

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: carvajal.C.Et al.(2021), a south american experience with postoperative complications following chest wall reconstruction for neoplasms, world journal of surgery, vol.10, pages 2892-2992 (colombia).The objective of this study is to report postoperative complications of chest wall resections for primary or secondary neoplasms in a south american cancer institution and their association with prosthesis reconstruction.Between november 2008 and october 2018, 77 patients underwent chest wall resection and reconstruction of primary or secondary neoplasms.There were 27 males and 50 females with a median age of 45.8 (range 3¿83 years).The implants used for this surgery were either a methyl methacrylate (mma), a polypropylene mesh (ppm), a stratos and a synthes matrixrib.The following complications were reported as follows: 55.5% of deaths occurred in the first 12 months after chest wall resection surgery.5 patients had intraoperative complications.2 lung lacerations that required lung sutures.3 vascular complications (1 subclavian vein lesion and 2 great vessel lesions; 1 of these patients died in surgery).2 patients had deep surgical site infection.1 patient had organ/site surgical site infection.This report is for an unknown synthes matrixrib.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: 12501141
• MDR Text Key: 272561998
• Report Number: 8030965-2021-07880
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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