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

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

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.

• Brand Name: UNK - SCREWS
• Type of Device: SCREW,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 Key: 9070506
• MDR Text Key: 158694645
• Report Number: 2939274-2019-60581
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• 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

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• 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
• Date Manufacturer Received: 08/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1