MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 18MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	04.613.518
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Hypoesthesia (2352)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remained implanted; as such explant date is not applicable.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is patient.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 an unknown date, the patient had an allergic reaction to devices implanted after an unknown surgery.Patient had itchiness, next patient turned red and had numbness from his neck to his left shoulder.The patient was implanted with a titanium vectra plate and four (4) titanium self-drilling screws on (b)(6) 2015 for an unknown procedure.The patient stated that he's allergic to nickel and wants to know if the implants contained the mineral.The symptoms of rash occurred almost immediately after surgery.No other information was provided.This report is for one (1) 4.0mm ti cervicle self-retain screw.This is report 5 of 5 for complaint (b)(4).

• Brand Name: 4.0MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 18MM
• 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: 8188485
• Report Number: 2939274-2018-55515
• Device Sequence Number: 16619628
• Product Code: KWQ
• UDI-Device Identifier: 10705034737669
• UDI-Public: (01)10705034737669
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/29/2018

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: 04.613.518
• Device Catalogue Number: 04.613.518
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 12/21/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Weight: 100