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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
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 matrixrib system/ unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k 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: sedaghat, n, et al. (2021), early outcomes of surgical stabilisation of traumatic rib fractures: single-center review with a real-world evidence perspective, journal of surgical research, volume 264, pages 222-229, (australia). The aim of this study was to investigate the outcomes of early experience with surgical stabilization of rib fractures. The secondary aim of this study was to investigate the preoperative characteristics, including indications for surgical stabilization of rib fractures as well as injury profile and time to operation. Between january 2013 to december 2018, 63 patients who underwent surgical stabilization of rib fractures were included in the study. The mean age was 55. 9 +/-14. 1 years and 55 patients were males. Surgical stabilization of rib fractures was completed using one of 2 systems: the unknown synthes matrixrib system and a competitor¿s plate fixation system. At the conclusion of the procedure, a chest tube is placed through the thoracoscopic port site. The chest tube was re- moved when there was no evidence of continuing air leak and minimal drain output (less than 200 ml/24 hour). The article did not specify which patients received the synthes or the competitor¿s device. Thus, complications will be reported as follows: 4 patients had wound infection requiring oral antibiotics. 2 patients had empyema requiring decortication. 1 patient had chest wall hematoma managed non-operatively. 1 patient had cardiac tamponade requiring a pericardial window. This was an intraoperative complication involving an epicardial laceration to the left ventricle during the open reduction internal fixation. This required formation of pericardial window intraoperatively, without any further postoperative complications. 12 patients had pneumonia. 9 patients had venous thromboembolism. 1 patient died secondary to palliation due to significant multi-system organ failure, unrelated to surgical stabilization of rib fractures. This report is for the unknown synthes matrixrib system. This report captures the reported events of wound infection. 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 Key12501770
MDR Text Key272431488
Report Number8030965-2021-07887
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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
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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