MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI VECTRA(TM) PLATE 3 LEVEL/54MM; APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

Model Number	04.613.254
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.The investigation could not be completed; no conclusion could be drawn.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.(b)(4).
Event or Problem Description
It was reported that a clinical study for a patient that underwent an anterior cervical discectomy fusion (acdf) at the c4-c7 levels on (b)(6) 2018.The patient was implanted with a titanium vectra plate, three (3) advanced acf spacers and a vivigen pouch.On (b)(6) 2018, the patient presented with c4-c5 interbody fracture of fusion mass; asymptomatic at time of evaluation.This report is for one (1) ti vectra(tm) plate 3 level/54mm.This complaint involves two (2) devices.This report is 1 of 2 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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
Patient's dysphagia began on (b)(6) 2019.Patient saw an ent surgeon who performed the anterior cervical dissection/approach for the ongoing issue.
Event or Problem Description
It was reported that a patient underwent an anterior cervical discectomy fusion (acdf) at the c4-c7 levels on (b)(6) 2018.The patient was implanted with a titanium vectra plate, unknown screws, three (3) vertigraft spacers with central lumen and a vivigen pouch.On (b)(6) 2018, the patient presented with c4-c5 interbody fracture of fusion mass; asymptomatic at time of evaluation.This was resolved with no residual effects on (b)(6) 2019.Concomitant devices reported: vivigen pouch (part# bl-1500-001, lot# unknown, quantity 1), vertigraft spacer with central lumen (part# 017709, lot# unknown, quantity 1), vertigraft spacer with central lumen (part# 017708, lot# unknown, quantity 1), vertigraft spacer with central lumen (part# 017708, lot# unknown, quantity 1).
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 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.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Event : updated modified event description provided for reporting.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
3/5/2019 & 04/02/2019: updated event description: it was reported that a patient underwent an anterior cervical discectomy fusion (acdf) at the c4-c7 levels on (b)(6) 2018.The patient was implanted with a titanium vectra plate, unknown screws, three (3) vertigraft spacers with central lumen and a vivigen pouch.On (b)(6) 2018, the patient presented with c4-c5 interbody fracture of fusion mass; asymptomatic at time of evaluation.On (b)(6) 2019, the patient experienced moderate intermittent dysphagia.This was resolved with no residual effects on (b)(6) 2019.Concomitant devices reported: vivigen pouch (part# bl-1500-001, lot# unknown, quantity 1), vertigraft spacer with central lumen (part# 017709, lot# unknown, quantity 1), vertigraft spacer with central lumen (part# 017708, lot# unknown, quantity 1), vertigraft spacer with central lumen (part# 017708, lot# unknown, quantity 1).This complaint involves two (2) devices.
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 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
Patient reported with intermittent dysphagia.

• Brand Name: TI VECTRA(TM) PLATE 3 LEVEL/54MM
• 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: 8034657
• Report Number: 2939274-2018-54749
• Device Sequence Number: 16525246
• Product Code: KWQ
• UDI-Device Identifier: 10705034737430
• UDI-Public: (01)10705034737430
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/05/2019

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: 04.613.254
• Device Catalogue Number: 04.613.254
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 01/24/2019; 01/29/2019; 03/05/2019; 03/05/2019
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 01/28/2019; 01/30/2019; 03/12/2019; 04/02/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 98