MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM TI CANCELLOUS POLYAXIAL SCREW 14MM; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number 04.614.014

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient weight was not provided for reporting.Date of event is unknown.Additional device product code: kwp, mnh, mni.Device remained implanted.Device was not explanted during revision surgery.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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 the patient had a c4-c6 posterior cervical spinal fusion on (b)(6) 2016 with synthes synapse.At an unknown point in time, the patient developed pain and degenerative disc disease below the c4-c6 fusion.On (b)(6) 2017 surgeon performed the revision procedure.During the revision, surgeon removed the existing locking caps (six) and rods (two).He left the existing screws (six) in place from c4-c6.There were no issues with the existing hardware.He then placed two new synapse screws at t1 and new rods and connected them.The new construct is c4-t1 with synthes synapse 3.5 mm rod system.Procedure was completed successfully.There was no surgical delay, no patient harm.Patient outcome was unknown.This report is for one (1) 3.5 mm ti cancellous polyaxial screw 14 mm.This is report 9 of 14 for (b)(4).

• Brand Name: 3.5MM TI CANCELLOUS POLYAXIAL SCREW 14MM
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7112896
• MDR Text Key: 94697248
• Report Number: 2939274-2017-50247
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 10705034738345
• UDI-Public: (01)10705034738345(10)LOT#UNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.614.014
• Device Catalogue Number: 04.614.014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR