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U.S. Department of Health and Human Services

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

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS SCREW,FIXATION,BONE Back to Search Results
Device Problem Unintended Movement
Event Type  Malfunction  
Manufacturer Narrative

This report is for an unknown screw/unknown lot. Part and lot numbers are unknown; udi number is unknown. Without a lot number the device history records review could not be completed. Product was not returned. 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: timlin, m. Et al. (1995), management of metastatic tumors to the spine using simple plate fixation, the american surgeon, vol 61, pages 704-708 (usa). The aim of this article is to present the management of metastatic tumors to the spine using simple plate fixation. From august 1986 to december 1990, a total of 28 patients with an average age of 61. 5 years, ranging from 25 to 81 years were treated with an unknown synthes dynamic compression plate and an unknown synthes ao cervical spine locking plate. The following complications were reported as follows: 28 patients died. 2 patients died within 1 week postop from respiratory complications. 15 of 17 patients with partial neurologic deficit improved at least 1 frankel grade. 2 patients didn't. 3 patients had rapid neurologic deterioration preop, or were neurologically complete at the time of surgery and did not have any neurologic improvement from decompression and stabilization. 24 of 28 patients had significant pain relief who required significantly less narcotics and the pain scale was relieved approximately 50 percent in this group. 4 patients didn't have significant pain relief. 1 patient who had been irradiated preoperatively and given corticosteroids developed an infection that resolved after irrigation and debridement. 1 patient had progression of the tumor in the sacrum and had asymptomatic loosening of a sacral screw. This is for an unknown synthes screw this is report 5 of 5 for (b)(4). A copy of the literature article is being submitted with this medwatch.

 
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Brand NameUNK - SCREWS
Type of DeviceSCREW,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 Key9070506
Report Number2939274-2019-60581
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 08/19/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/16/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received08/19/2019
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

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