MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI VECTRA(TM) PLATE 3 LEVEL/48MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	04.613.248
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Only event year is known.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.Product was not returned.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.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 on (b)(6) 2020, the patient underwent a revision procedure due to loosening.On (b)(6) 2020 the patient underwent a three level anterior cervical discectomy and fusion (acdf) where a 48mm vectra cervical plate was implanted with eight (8) 4.0x18 mm vectra variable angle screws.A few days after the case the patient had a coughing attack significant enough to visit the er.No implant issues were reported at that time.On (b)(6) 2020 the patient visited the clinic with discomfort in his neck.X-rays and a ct scan were ordered and the loose plate with three backed out screws was discovered.Based on the ct findings, the implant loosening appeared to have happened a month or more earlier due where the screw tracks would have been.During the revision procedure the original implants were removed and successfully replaced with a 45mm vectra plate and longer 4.5 x 20mm vectra screws.It is believed that the patient suffered no internal damage from loose hardware based on an inspection of the wound during the revision procedure.The explanted cervical plate was briefly inspected by the surgeon and discarded; it did not appear to be damaged.The surgeon believes that the patient¿s coughing event shortly after his june surgery combined with non-compliance with wearing his collar and recreational drug use led to the implant loosening.The patient tolerated the surgery well and was to be discharged from the hospital on (b)(6) 2020.Concomitant device reported: screws (part number unknown, lot unknown, quantity 5).This report involves one (1) ti vectra(tm) plate 3 level/48mm.This is report 1 of 4 for pc-(b)(4).

• Brand Name: TI VECTRA(TM) PLATE 3 LEVEL/48MM
• 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: 10487595
• Report Number: 2939274-2020-03950
• Device Sequence Number: 11794615
• Product Code: KWQ
• UDI-Device Identifier: 10705034737416
• UDI-Public: (01)10705034737416
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K050451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2020

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: 04.613.248
• Device Catalogue Number: 04.613.248
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 09/03/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS; UNK - SCREWS; UNK - SCREWS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR