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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  Injury  
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. 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. (b)(4).

 
Event Description

This report is being filed after the review of the following journal article: zaveri, g. R. And ford, m. (2001), cervical spondylosis: the role of anterior instrumentation after decompression and fusion, journal of spinal disorders, vol. 14 (1), pages 10-16 (canada). The aim of this study is to evaluate the use of instrumentation in anterior cervical decompression and fusion with respect to 1. The advantages, including more consistent fusion, reduced graft-related complications, and maintenance of intraoperative sagittal alignment correction; 2. Potential problems, including infection, hardware failure, and accelerated adjacent level disease; and 3. A comparison of these results with literature on the outcome of fusion without instrumentation. Between 1989 to 1997, a total of 47 patients (25 male and 22 female) with an age of 28 to 76 years (mean, 58. 1 years) were included in the study. Surgery was performed using a titanium hollow screws and plate (synthes, paoli, pa, u. S. A. ) in the first 9 cases, and the ao anterior cervical spine locking plates (synthes) in the other 38 patients. The following complications were reported as follows: 7 patients had evidence of accelerated changes at the level adjacent to the fusion mass on serial radiographs, as shown by reduced disk height, formation of osteophytes, or instability. Three of them were symptomatic, and the diagnosis of spinal cord¿root compression at that level was confirmed with a gadolinium enhanced mri. Although one patient responded to nonoperative treatment, the other two required another operation and, in fact, one of them experienced an ¿add-on syndrome¿ and required two more procedures at levels adjacent to previous fusions. 1 patient had wound hematoma. 2 patients had a prolonged postoperative dysphagia, but this gradually improved during a period of 6 months. 2 patients had nonunion. One of them is a female patient who had a fractured plate and reported a feeling of movement in her neck and dysphagia. At repeated exploration, the plate was removed and the pseudoarthrosis was confirmed. The other patient experienced radiographic haloes around the screw. 1 patient had 2 inferior screws that fractured at the plate-bone interphase. A solid fusion developed but with moderate local kyphosis. 2 patients had loosened screws (4) as indicated by the development of haloes around the screws. One of these patients had 2 loose screws that backed out partially along with the plate. This report is for one (1) screw. This is report 6 of 8 for (b)(4).

 
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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 Key8950240
Report Number2939274-2019-60240
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 08/02/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/30/2019
Is This An Adverse Event Report? Yes
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 Received08/02/2019
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: 08/30/2019 Patient Sequence Number: 1
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