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

Model Number	6081223
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Rash (2033)
Date of Event	09/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The index surgery was reported to have occurred in (b)(6) 2014.The patient reported that following the anaphylaxis event (details unknown).The construct was reported to have been altered to remove the cobalt-chromium rods and replaced with titanium rods.The date of this revision is unknown.Following this, a request for peek material samples was received from the patient.A peek sample was provided to the patient on (b)(6) 2015 to facilitate determination of sensitivity to the peek material.No device has been returned for evaluation.No radiographs have been provided.No sensitivity testing results have been received.The root cause of this reported event has not been determined.Biocompatibility of the peek material has been assessed in accordance with iso 10993 requirements.Labeling review: ".Contraindications: contraindications include, but are not limited to: infection, local to the operative site.Signs of local inflammation.Patients with known sensitivity to the materials implanted." ".Potential risks identified with the use of this system, which may require additional surgery, include:.Metal sensitivity or allergic reaction to a foreign body".".Caution must be taken due to potential patient sensitivity to materials.Do not implant in patients with known or suspected sensitivity to the aforementioned materials.Exercise caution when choosing implant sizes, as larger implants may not be suitable".Device not returned.
Event or Problem Description
On (b)(6) 2014 a female patient underwent a construct implantation at l4-s1.On (b)(6) 2016 nuvasive was notified the patient suffered an allergic reaction to polyetheretherketone (peek) that subsequently resulted in explantation.The patient was reported to have suffered an anaphylactic reaction approximately three weeks after the index surgery.

• 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: 6038169
• Report Number: 2031966-2016-00076
• Device Sequence Number: 758320
• Product Code: MAX
• UDI-Device Identifier: 00887517283863
• UDI-Public: 00887517283863
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Model Number: 6081223
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2016
• Initial Report FDA Received Date: 10/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR