MAUDE Adverse Event Report: ULRICH MEDICAL ADD PLUS; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	CS 2253-12-40
Health Effect - Clinical Code	Paresis (1998)
Date of Event	09/07/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Literature nigro l., tarantino, r., donnarumma, p., santoro, a., & delfini, r.(2017).C5 palsy after insertion of a winged expandable cervical cage: a case report and literature review.Journal of spine surgery.Study reported case study in which pt was implanted with addplus device for three-level anterior cervical corpectomy and fusion resulting in c5 palsy."we suppose that the preexisting foraminal stenosis, wide anterior decompression and partial improvement of cervical alignment were all factors contributing to the palsy.".

• Brand Name: ADD PLUS
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): ULRICH MEDICAL
• MDR Report Key: 6753661
• Report Number: MW5071288
• Device Sequence Number: 1116591
• Product Code: MQP
• UDI-Device Identifier: 04052536009381
• UDI-Public: 04052536009381
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CS 2253-12-40
• Device Catalogue Number: CS 2253-12-40
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 66 YR