MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM TI CERV SELF-RETAIN SCR SLF-TPNG/VARIABLE ANGLE 20MM; APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

Model Number	04.613.620
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Dysphagia/ Odynophagia (1815)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 report that the patient had original surgery on (b)(6) 2018 for treatment of an anterior cervical discectomy fusion at c5-c7 disc levels due to degenerative disc disease.Patient was implanted with one (1) unknown vectra plate and six (6) vectra 20mm self-tapping screws.Post-operatively, within 2 weeks of implantation, patient presented with one (1) of the screws backing out at the patients left side c5 disc level.Presently, patient has difficulty swallowing.No revision surgery has been scheduled at this time.Sales consultant has no more information to report on this event.Concomitant devices reported: 4.0mm ti cervical self retaining/ self tapping /variable angle screw (part 04.613.620, lot number unknown, quantity 5), vectra plate part number unknown, lot number unknown, quantity 1).This report is for one (1) 4.0mm cervical self retaining screw.This is report 1 of 1 for (b)(4).

• Brand Name: 4.0MM TI CERV SELF-RETAIN SCR SLF-TPNG/VARIABLE ANGLE 20MM
• Common Device Name: APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7390937
• Report Number: 2939274-2018-51384
• Device Sequence Number: 70155
• Product Code: HWC
• UDI-Device Identifier: 10705034737850
• UDI-Public: (01)10705034737850(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.613.620
• Device Catalogue Number: 04.613.620
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2018
• Initial Report FDA Received Date: 04/02/2018
• 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 Weight: 100