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

Model Number	7734117
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/28/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographs confirming the event have been received.Revision surgery has not occurred to date.The patient reported no inordinate trauma/impacts, but related he had been able to return to activities of daily living without pain until (b)(6) 2016.No construct revision has occurred to date.Root cause cannot yet be identified.Labeling review: "potential risks identified with the use of this device system, which may require additional surgery, include: bending, fracture or loosening of implant components.These devices can break when subjected to the increased load associated with delayed union or non-union.Internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs.If healing is delayed, or does not occur, the implant may eventually loosen, bend, or break.Loads on the device produced by load bearing and by the patient's activity level will dictate the longevity of the implant." implant remains in-situ.
Event or Problem Description
A (b)(6) year-old patient underwent a single-level acdf procedure at c5-6 on (b)(6) 2014.Approximately (b)(6) 2016 the patient reported a return of radicular symptoms with numbness.Evaluation conducted february 22, 2017 noted a screw fracture in the c6 vertebral body.Revision of the index surgery construct is anticipated.No injury has been reported.

• Brand Name: HELIX MINI 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: 6530333
• Report Number: 2031966-2017-00046
• Device Sequence Number: 19042654
• Product Code: KWQ
• UDI-Device Identifier: 00887517091758
• UDI-Public: 00887517091758
• Combination Product (Y/N): N
• PMA/510(K) Number: K073275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 08/27/2015

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: Physician
• Device Model Number: 7734117
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2017
• Initial Report FDA Received Date: 04/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR