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

Model Number	7739215
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation as no revision procedure has been conducted.A review of the x-rays provided confirm the reported event.Labeling review: ".Important: prior to locking bone screws into the plate, ensure that all bone screws are inserted (driven) 75% into bone prior to final tightening.Failure to do so may reduce the chance of properly locking the bone screw into the plate construct post-operative warnings: ".During the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration as well as to other complications.To ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques.".
Event or Problem Description
Received information stating patient was experiencing a screw back out 11 weeks postoperative.At this time there is no revision procedure scheduled nor patient injury reported.
Additional Manufacturer Narrative
Received new information that indicates patient underwent a revision procedure two to three weeks post-operative where screw was re-locked down.No product has been returned for investigation as it remained in-situ.
Additional Manufacturer Narrative
Received new information that indicates patient underwent a revision procedure two to three weeks post-operative where screw was re-locked down.No product has been returned for investigation as it remained in-situ.

• 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: 7754435
• Report Number: 2031966-2018-00125
• Device Sequence Number: 1719895
• Product Code: KWQ
• UDI-Device Identifier: 00887517094711
• UDI-Public: 00887517094711
• Combination Product (Y/N): N
• PMA/510(K) Number: K083341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2018

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: 7739215
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1