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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PLATES: SPINE PLATE, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PLATES: SPINE PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Laceration(s) (1946); Nerve Damage (1979); Non-union Bone Fracture (2369); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown anterior tension band 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. (b)(4).
 
Event Description
This report is being filed after the review of the following journal article: wood k, et al (2006), interim evaluation of prospective multi-center outcome study of anterior lumbar plating for one- and two-level degenerative disc disease, the spine journal, volume 6, page 116s, (usa). The primary objective of this prospective study is to measure radiographic fusion success in patients with lumbar degenerative disc disease using an anterior lumbar plating system. The secondary objective is to accurately define the clinical benefits to the patient. There were 99 patients enrolled in the study, 81 of whom have undergone surgery. There were 41 females 39 males with available baseline data. The mean age was 45. 0 years (range, 23-78 years). Patients underwent anterior lumbar interbody fusion (alif) using an unknown synthes anterior tension band plate system. Patients were evaluated at 3-month, 6-month, 12-month, and 24-month intervals postoperatively. Complications were reported as follows: 5 patients had no fusion at 12 months follow-up. 4 were two-level alif procedure patients who had one of the two levels fused, but not the other. 1 patient had vena cava laceration which was resolved intraoperatively. 1 patient had left iliac vein tear which was resolved intraoperatively. 1 patient had suture removal postoperatively. 1 patient had deep vein thrombosis. 2 patients had stretch neurapraxia. This report is for unknown synthes anterior tension band plate. It captures the reported event of no fusion, vena cava laceration, left iliac vein tear, suture removal, deep vein thrombosis and stretch neurapraxia. This is report 1 of 2 for complaint (b)(4).
 
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Brand NameUNK - PLATES: SPINE
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 Key9591637
MDR Text Key188389285
Report Number2939274-2020-00199
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
Type of Report Initial
Report Date 12/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2020
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 Received12/20/2019
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: 01/15/2020 Patient Sequence Number: 1
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