MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE RELINE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	11108055
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924); Pain (1994)
Date of Event	10/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event was reported via mw5066797.No films were received that confirmed the event.The available information suggests a prior surgery had occurred and the procedure on (b)(6) 2016 was an extension of the prior construct; no details of the prior surgery are known.Circumstances further suggest the patient may have lost their balance and the impact separated the connector components.Status post-revision of the fractured connector has been reported to be good.Explanted device was discarded by the user facility.No further evaluation of this component can be performed.Review of manufacturing records of the material type indicate no non-conformances have been observed.Literature review: ".Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)." ".Loads on the device produced by load bearing and by the patient's activity level will dictate the longevity of the implant." ".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." device discarded by user facility.
Event or Problem Description
A female patient underwent a posterior fixation procedure on (b)(6) 2016.Shortly after this procedure she sat down hard on a seat that was lower than expected and noticed pain and a loud snapping/cracking sensation.Evaluation included radiographs which noted rod-to-rod connector had fractured.On (b)(6) 2016 she had a revision surgery to remove and replace the fractured device.
Additional Manufacturer Narrative
A review of the complaint file indicates the incorrect part number was used in the initial mdr.Has been updated on the mdr report has been updated.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6316176
• Report Number: 2031966-2017-00004
• Device Sequence Number: 10770945
• Product Code: NKB
• UDI-Device Identifier: 00887517535078
• UDI-Public: 00887517535078
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2017

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: 11108055
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2017
• Supplement Date Received by Manufacturer: 01/11/2017
• Initial Report FDA Received Date: 02/09/2017
• Supplement Report FDA Received Date: 09/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1