MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI VECTRA(TM) PLATE 3 LEVEL/51MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	04.613.251
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Dysphagia/ Odynophagia (1815)
Date of Event	05/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Difficulty swallowing began on an unknown date in (b)(6) 2018.Device has not been reported as explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter address and phone number were not available for reporting.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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 a patient underwent an anterior cervical discectomy fusion (acdf) procedure at the c4-c7 levels on (b)(6) 2018.The patient was implanted with one (1) vectra 51 mm plate, three (3) 7 mm spacers with central lumen, and one (1) 1 cc vivigen pouch.Postoperatively, on (b)(6) 2018 the patient presented with difficulty swallowing.The patient was treated with a medrol dose pack, and the outcome was reported as recovered/resolved with no residual effects.On (b)(6) 2018, the patient presented with swelling in the neck.Concomitant devices reported: biologic tissue matrix: vivigen (part bl-1500-001, lot 1811149-8027, quantity 1 cc cell bone); 7 mm acf spacer (part 017207, lot 00514025521027, quantity 1); 7 mm acf spacer (part 017207, lot 00514025521028, quantity 1); 7 mm acf spacer (part 017207, lot 00616061301055, quantity 1) this report is to capture the difficulty swallowing.The swelling in the neck will be captured on related (b)(4).This is report 1 of 2 for (b)(4).

• Brand Name: TI VECTRA(TM) PLATE 3 LEVEL/51MM
• 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: 7863927
• Report Number: 2939274-2018-53705
• Device Sequence Number: 13956446
• Product Code: KWQ
• UDI-Device Identifier: 10705034737423
• UDI-Public: (01)10705034737423
• Combination Product (Y/N): N
• PMA/510(K) Number: K050451
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/22/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.613.251
• Device Catalogue Number: 04.613.251
• Device Lot Number: 11169
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 09/11/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 39 YR
• Patient Weight: 69