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U.S. Department of Health and Human Services

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

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Non-union Bone Fracture (2369); Osteolysis (2377); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This report is for one (1) unknown variable angle (va) olecranon plate/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. (b)(4). 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
It was reported that a patient underwent the removal of a variable angle (va) olecranon plate and screws and another company radial head prosthesis on (b)(6) 2019 due to nonunion with bone loss. Open reduction internal fixation (orif) revision surgery of olecranon was performed and the patient was implanted with fibular strut and a new plate screw construct. X-ray taken on an unknown date revealed bone loss. Initially orif radial head and olecranon using the synthes radial head plate and olecranon plate was done on (b)(6) 2018. Revision surgery was done on (b)(6) 2018, due to consistent radial head dislocation under the same surgeon at an unknown location performed removal of hardware of radial head plates and conversion to acumed radial head replacement and repair or of tissues. This report captures second revision surgery due to nonunion with bone loss. The first revision surgery performed on (b)(6) 2018 due to consistent radial head dislocation has been reported under related complaint (b)(4). Concomitant devices reported: unk - radial head prosthesis (part# unknown, lot# unknown, quantity# 1). This report is for one (1) unknown variable angle (va) olecranon plate. This is report 1 of 2 for complaint (b)(4).
 
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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 Key8528681
MDR Text Key142396346
Report Number2939274-2019-57549
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2019
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 Received05/09/2019
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: 04/18/2019 Patient Sequence Number: 1
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