MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ACIS IMPLANT LORDOTIC/STANDARD 9MM HEIGHT; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

Model Number	08.843.009
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient¿s height reported as 64 inches.Additional patient identifier reported as (b)(6).Date of postoperative pain development is unknown.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.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 reported that the patient underwent an anterior cervical discectomy and fusion (acdf) procedure using vivigen cellular bone matrix at the c5-c7 levels on (b)(6) 2017, where the patient was implanted with a vectra plate, two spacers with central lumen, a vivigen pouch and a distractor pin.Post-operatively, on (b)(6) 2018, the patient had a fall in shower that resulted in headache, hip pain, and small laceration.On (b)(6) 2018, the patient presented again with hip pain.Concomitant device reported: unk - biologic tissue matrix: vivigen (part # unknown, lot unknown, quantity 1); distractor pin 12mm (part # 02.600.022, lot # unknown, quantity 1).This report is for one (1) acis implant lordotic/standard 9mm height.This is report 3 of 4 for complaint (b)(4).

• Brand Name: ACIS IMPLANT LORDOTIC/STANDARD 9MM HEIGHT
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7864507
• Report Number: 2939274-2018-53722
• Device Sequence Number: 1938879
• Product Code: ODP
• UDI-Device Identifier: 10705034761640
• UDI-Public: (01)10705034761640
• Combination Product (Y/N): N
• PMA/510(K) Number: K120275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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: 08.843.009
• Device Catalogue Number: 08.843.009
• 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: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 101