MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE COROENT SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	6908855
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Damage to Ligament(s) (1952)
Date of Event	10/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device has been returned for evaluation.It was reported that during the placement/fracture of 8mm devices that the all may have been compromised, resulting in additional instability, necessitating placement of a 10mm implant.Post-op radiographs were received confirming proper placement of the 10mm implant.The root cause of this reported event is unknown, however review of the operational notes indicate implant size selection or anatomical characteristics of the patient contributed to the event.There is no plan for revision.Labeling review: ".Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s), loss of fixation, nonunion or delayed union, fracture of the vertebra, neurological, vascular or visceral injury, metal sensitivity or allergic reaction to a foreign".".Correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant.While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants." device not returned to manufacture.
Event or Problem Description
A (b)(6) underwent a lateral procedure in which three 8mm interbody devices reportedly fractured during impaction.The fourth cage was succesfully placed but the surgeon decided to upsize to a 10mm cage due to possible all damage.

• Brand Name: NUVASIVE COROENT SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6082721
• Report Number: 2031966-2016-00081
• Device Sequence Number: 16333109
• Product Code: MAX
• UDI-Device Identifier: 00887517389718
• UDI-Public: 00887517389718
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K141665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/07/2016

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: 6908855
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2016
• Initial Report FDA Received Date: 11/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 57