MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM TI CANCELLOUS POLYAXIAL SCREW 12MM; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	04.614.012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional 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).Used to capture additional medical/surgical intervention required.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 or Problem 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 3.5mm rod system.Procedure was completed successfully.There was no surgical delay, no patient harm.Patient outcome was unknown.This report is for one (1) 3.5mm ti cancellous polyaxial screw 12mm.This is report 8 of 14 for (b)(4).

• Brand Name: 3.5MM TI CANCELLOUS POLYAXIAL SCREW 12MM
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7112873
• Report Number: 2939274-2017-50246
• Device Sequence Number: 16439709
• Product Code: NKG
• UDI-Device Identifier: 10705034738338
• UDI-Public: (01)10705034738338(10)LOT#UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K142838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 04.614.012
• Device Catalogue Number: 04.614.012
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 12/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR