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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - RODS: MATRIX ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - RODS: MATRIX ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Catalog Number UNK - RODS: MATRIX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Pain (1994)
Event Type  Injury  
Manufacturer Narrative

This report is for an unk - rods: matrix / unknown lot. Part and lot numbers are unknown; udi number is unknown. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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. 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.

 
Event Description

It was reported that on an unknown date, the patient underwent posterior lumbar revision of matrix system, six (6) screws, six (6) locking caps, and two (2) rods, due to pain. There was no mention of adjacent level disease. The surgeon used a laser during the initial surgery to control bleeding. The initial surgery was in 2016. There was metal debris in the wound and it was arching during electrocautery. Lab was testing material and tissue. Irrigation and debris were emended. The patient was having pain was the reason for the revision, there was no mention of adjacent level disease. The patient was implanted with a competitor¿s implant at the same levels. It is unknown if there was surgical delay. Procedure and patient outcome were unknown. (b)(4).

 
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Brand NameUNK - RODS: MATRIX
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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 Key9383245
MDR Text Key168586188
Report Number2939274-2019-62412
Device Sequence Number1
Product Code NKB
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,Followup
Report Date 10/31/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/27/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK - RODS: MATRIX
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 Received12/10/2019
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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