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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PLATES, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC PLATES, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthritis (1723); Bone Fracture(s) (1870)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown - plate/unknown lot number. Without the specific part number, the udi number and 510k 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 as no product was received. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. 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. (b)(4).
 
Event Description
This report is being filed after the review of the following journal article: j. Sebastiaan souer el. Al (2009), comparison of ao type-b and type-c volar shearing fractures of the distal part of the radius, the journal of bone & joint surgery vol. 91(11), pages 2605-2611 (usa) doi:10. 2106/jbjs. H. 01479. The aim of this article is to investigate the relative incidence of volar marginal articular fractures with and without a concomitant fracture of the dorsal metaphyseal cortex (i. E. , we compared type-b and type-c oblique volar marginal articular fractures with volar radiocarpal subluxation) and tested the null hypothesis that there is no difference between these two fractures with regard to wrist function or health status after open reduction and plate-and-screw fixation. Between 2001 to 2004, type b- volar shearing fractures with a total of 20 patients (11 male and 9 female) with a mean age of 49 years (ranges 20-80 years) were included in the study. 11 fractures were treated with a 2. 4 mm locking compression plate, 5 patients were treated with 3. 5-mm locking compression plate, and 2 patients treated with t-shape nonlocking plate. The mean duration of follow-up was unknown. The following complications were reported as follows: 2 patients had an intra-articular step-off base on radiographic evaluation at the 2 year follow-up. Grade-1 radiocarpal arthritis was found in 7 patients. Grade -2 radiocarpal arthritis was found in 2 patients. This report is for a synthes 2. 4 mm locking compression plate (lcp), 3. 5 mm locking compression plate (lcp) synthes titanium t-shaped nonlocking plate and stainless t-shaped nonlocking plate. This ips captures the following complications: 2 patients had an intra-articular step-off base on radiographic evaluation at the 2 year follow-up. Grade-1 radiocarpal arthritis was found in 7 patients. Grade -2 radiocarpal arthritis was found in 2 patients. This report is for one (1) unk - plates this is report 5 of 8 for (b)(4). A copy of the literature article is being submitted with this medwatch.
 
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Type of DevicePLATES, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8613890
MDR Text Key145249607
Report Number2939274-2019-58061
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 04/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2019
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 Received04/16/2019
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: 05/15/2019 Patient Sequence Number: 1
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