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	Swelling (2091)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is unknown.Product has not been explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Facility and contact information is unknown.Reporter is a synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review 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 51mm plate, three (3) unknown 7mm spacers with central lumen, and one (1) 1cc vivigen pouch.Postoperatively, on (b)(6) 2018, the patient presented with difficulty swallowing, and on (b)(6) 2018, the patient presented with swelling in the neck.As of (b)(6) 2018, both events have resolved.Concomitant devices: vivigen (part: unknown, lot: unknown, quantity: 1cc); acf spacer-lordotic 7mm (part: 017207, lot: 00514025521027, quantity: 1); acf spacer-lordotic 7mm (part: 017207, lot: 00514025521028, quantity: 1); acf spacer-lordotic 7mm (part: 017207, lot: 00616061301055, quantity: 1).This report is for a titanium (ti) vectra(tm) plate 3 level/51mm.This is report 1 of 2 for (b)(4) and will capture the swelling in the neck.The patient¿s difficulty swallowing is captured in (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device history record (dhr) review: part #: 04.613.251; lot #: 1-116-9.Provided lot number is not valid, this is not a 7-digits standard synthes lot number, therefore no dhr review possible.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.

• 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: 7890236
• Report Number: 2939274-2018-53847
• Device Sequence Number: 16825871
• Product Code: KWQ
• UDI-Device Identifier: 10705034737423
• UDI-Public: (01)10705034737423
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• 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
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 10/02/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THERAPY DATE: (B)(6) 2018; THERAPY DATE: (B)(6) 2018
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Weight: 69