MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 16MM; APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

Model Number	04.613.516
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event occurred on an unknown date in 2018.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.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 on (b)(6) 2018, the patient was implanted with a cervical vectra plate.On an unknown date in 2018, the patient then began to experience unspecified allergic symptoms.The patient felt it was due to a nickel sensitivity or allergy.This report is for one (1) 4.0mm ti cerv self-retain scr slf-drlg/variable angle 16mm.This is report 2 of 2 for (b)(4).

• Brand Name: 4.0MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 16MM
• 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: 7926291
• Report Number: 2939274-2018-54056
• Device Sequence Number: 13966153
• Product Code: KWQ
• UDI-Device Identifier: 10705034737645
• UDI-Public: (01)10705034737645
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K071667
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/07/2018

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: 04.613.516
• Device Catalogue Number: 04.613.516
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 10/02/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR