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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 Problems Pain (1994); Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown matrixrib locking plate construct/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: zhang d, et al. (2021), minimally invasive surgery rib fracture fixation based on location and anatomical landmarks, european journal of trauma and emergency surgery, pages 1-10 (china). This study aimed to clarify the definition of zhang zhifei (zzf) zoning method, and to retrospectively analyze the clinical efficacy of zzf zoning method on the selection of incision and approach in 110 selected patients undergoing minimally internal fixation for rib fracture. From july 2017 to july 2019, 110 rib fracture patients with 3 or more unilateral dislocations (axial ct chest imaging measurements represented 50 percent of the rib width) and underwent selective open reduction and internal fixation for rib fractures were included in the study. There were 73 males and 37 females with a mean age of 52 years (range, 25-73 years). Pure titanium embracing fixator or pre-shaped rib locking plate was selected for fixation according to the anatomical characteristics and operation of the fracture site which included the unknown synthes matrixrib locking plate. During the operation, a 14f drainage tube was routinely placed between the rib surface muscle layers of the chest wall. In patients with parietal pleura damage, 22f closed thoracic drainage tube was placed in the 6th or 7th intercostal space of the mid-axillary line the drainage tube in chest wall was pulled out within 48 hours postoperatively. If the thoracic drainage volume was less than 100 ml at 24 h ours after the operation, and if there was no obvious liquid pneumothorax after re-examination of chest line or computed tomography of lung inflation, the closed thoracic drainage tube was pulled out. The article did not specify which patients were implanted with the synthes devices. Thus, complications will be reported as follows: 2 patients had postoperative wound infections, both healed in a short-term period after active dressing changes. 2 patients had subcutaneous effusion that were cured by multiple suction and pressure dressing. 1 patient had a removal of internal fixation 1 year after the operation due to continuous chest pain. The pain was significantly relieved and ultimately disappeared 3 months later. This report is for the unknown synthes matrixrib locking plate construct. This is report 1 of 1 for complaint (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 Key12501871
MDR Text Key272437352
Report Number8030965-2021-07888
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeCH
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
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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