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U.S. Department of Health and Human Services

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

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SYNTHES GMBH UNK - CONSTRUCTS: MATRIXRIB PLATE/SCREWS PLATE,FIXATION,BONE Back to Search Results
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).
 
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Brand NameUNK - CONSTRUCTS: MATRIXRIB PLATE/SCREWS
Type of DevicePLATE,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 Key12501141
MDR Text Key272561998
Report Number8030965-2021-07880
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeCO
Number of Events Reported1
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 Received09/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK - CONSTRUCTS: MATRIXRIB PL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2021
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?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/20/2021 Patient Sequence Number: 1
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