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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: MATRIXRIB PLATE/SCREWS PLATE, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 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 Insufficient Information (4580)
Event Type  Death  
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803. This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date. This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report. If the information is unknown, not available or does not apply, the section/field of the form is left blank. : this report is for an unknown matrixrib construct/unknown lot. Part and lot numbers are unknown; udi 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: niziolek, g. Et al (2022), ¿early results after initiation of a rib fixation programme: a propensity score matched analysis¿, injury, vol. 53 (xx), pages 137¿144 (usa). The aim of this propensity score matched analysis is to compare non-operative management of patients with severe chest wall injury with those patients undergoing surgical stabilisation of rib fractures (ssrf). Over the period of study, a total of 45 patients underwent ssrf (all-ssrf). The first 22 patients from this cohort were used as described above for matching (early-ssrf). All patients undergoing ssrf were plated with the matrixrib fixation system (depuy synthes, raynham, ma). A total of 2,447 patients with blunt chest injury underwent propensity match analysis which, after screening for indications and contraindications, yielded 36 patients in the non-op cohort. The mean follow-up period was unknown. The following complications were reported as follows: 1 patient died/30-day mortality. 21 patients had pulmonary complications: respiratory failure > 48 hours (n
=
19), pneumonia (n
=
12), acute respiratory distress syndrome (n
=
1), unplanned intubation (n
=
7). 2 patients had cardiac complications: mi (n
=
2) and cardiac arrest (n
=
1). 14 patients had infectious complications: pneumonia (n
=
12), wound infection (n
=
3), cauti (n
=
2). 4 patients had 30-day readmission. 1 patient from early-ssrf had their hardware removed at 9 months for pain from the hardware. This is report 2 of 2 for (b)(4). This report is for an unknown synthes matrixrib constructs.
 
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Brand NameUNK - CONSTRUCTS: MATRIXRIB PLATE/SCREWS
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14980798
MDR Text Key295671498
Report Number2939274-2022-02596
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2022
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
Date Manufacturer Received06/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/11/2022 Patient Sequence Number: 1
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