MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE HELIX-T ACP SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	7781362
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Fall (1848)
Date of Event	08/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was returned and visual inspection confirmed plate separated at the middle translation joint.A review of the returned explanted screws found no significant markings.All four of the outer screw ports on the plate show screw contact marks on the edge side, likely from force contact as a result of the patients fall.The center translational tab has separated from the mating port with no significant damage or contact marks, however the flat spring utilized as the translational stop is missing.When this spring is not in place the plate disassembles and will not load on inserter and cannot be implanted in that state.The lateral translation joints tested normally with no issue identified.Summary of investigation is consistent with a substantial patient fall creating separation forces that exceed what the flat nitinol spring can withstand.Labeling review: ".Patient education: preoperative instructions to the patient are essential.The patient should be made aware of the limitations of the implant and potential risks of the surgery.The patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components.The patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed." ".Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s).".
Event or Problem Description
Patient underwent a c5 level corpectomy with a non nuvasive cage and a helix-t plate on (b)(6) 2018.Reportedly, the patient suffered a fall five days post-surgery and underwent a revision procedure due to a broken plate.No cage dislodging nor fractures to the vertebral body or screws were noted.

• Brand Name: NUVASIVE HELIX-T ACP SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 7846215
• Report Number: 2031966-2018-00139
• Device Sequence Number: 19155927
• Product Code: KWQ
• UDI-Device Identifier: 00887517120762
• UDI-Public: 00887517120762
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K083341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/05/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7781362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 09/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1