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

Model Number	7756545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation.Radiographic images were reviewed and confirm the reported event of broken screw.Patients bone quality was not provided nor patients post-operative activities.Potential adverse events and complications ".As with any major surgical procedures, there are risks involved in orthopedic surgery." ".Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s); nonunion or delayed union." ".These devices can break when subjected to the increased load associated with delayed union or nonunion.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." ".Patient education: preoperative instructions to the patient are essential.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." 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." no product has been returned.
Event or Problem Description
Received information stating on (b)(6) 2017 patient underwent a revision procedure to replace broken screws.No indication of patient harm or serious injury provided.
Additional Manufacturer Narrative
Product has been returned for evaluation and alleged event has been confirmed.The returned parts have been examined, minor damage to the tulip threads that appear to be from the removal was viewed.Shanks fractured at the neck proximal to the head was also viewed.The fractures are consistent with excessive load force, possibly indicating the load was not being properly shared with the implant.The screws had been implanted for 17 months.It is unknown if the patient complied with post-operative restrictions.A review of pre and post x-rays performed by medical director and confirm no broken rods, screws or disconnected components.

• Brand Name: NUVASIVE SPHERX SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 7148171
• Report Number: 2031966-2017-00190
• Device Sequence Number: 16600187
• Product Code: NKB
• UDI-Device Identifier: 00887517098993
• UDI-Public: 00887517098993
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K090981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2018

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: Physician
• Device Model Number: 7756545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR