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U.S. Department of Health and Human Services

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

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: PLATE/SCREWS PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthritis (1723); Necrosis (1971); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
510k: this report is for an unknown plate and screw construct/unknown lot. Part and lot number 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. (b)(4). 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: liskutin t. , et al (2020) the influence of biplanar reduction and surgeon experience on proximal humerus fractures treated with orif, injury volume 51, pages 322¿328 (usa). This retrospective case series aims to determine if measures of preoperative deformity and postoperative reduction quality in both the sagittal and coronal planes were associated with the primary outcome, complications, for patients with ao/ota c-type proximal humerus fractures treated with orif using a locking plate. Between january 2008 and january 2017, a total of 41 patients (26 females, 14 males) average age was 58. 5 years (range 20. 5¿98. 1 years, std dev 14. 3 years)with ao/ota c-type proximal humerus fractures treated with open reduction and internal fixation (orif) were included in the study. Orif was performed utilizing a proximal humerus internal locking system (philos) plate (synthes, raynham, ma, usa). Mean follow-up time was 42 months (range 3 to 128 months). The following complications were reported: the medial calcar was disrupted in 20 of the 41 fractures. Both reliability measures of coronal displacement were poor. Complications occurred in 11 of 35 patients, including avn (7), post-traumatic arthritis (1), and impingement (1). Re- operation was required for 7 patients. Loss of reduction/screw cutout (2) (complications that occurred in 11 of 35 patients). This report is for an unknown synthes proximal humerus internal locking system (philos) plate. This is report 1 of 3 for (b)(4).
 
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Brand NameUNK - CONSTRUCTS: 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
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10773974
MDR Text Key214316426
Report Number2939274-2020-04938
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
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2020
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 Received11/02/2020
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: 11/02/2020 Patient Sequence Number: 1
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