MAUDE Adverse Event Report: NUVASIVE INC NUVASIVE POLYAXIAL SPINAL SCREWS; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	8806555A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product returned for evaluation, per hospital sterilization policy.Radiograph provided confirmed screw fracture.It is unknown if patient observed post-op physical restrictions.Root cause has not been established.Label review ".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." ".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." ".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.Metallic internal fixation devices cannot withstand the activity levels and/or loads equal to those placed on normal, healthy bone.These devices are not designed to withstand the unsupported stress of full weight or load bearing alone.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." no product returned.
Event or Problem Description
A patient underwent a posterior lumber interbody fusion procedure on a unknown date.As per reporter physician observed final fusion.On (b)(6) 2019 patient underwent a procedure to remove the construct.During the removal process it was observed that the right l5 screw had fractured.A fractured portion of the screw remains in the patient as it could not be removed.

• Brand Name: NUVASIVE POLYAXIAL SPINAL SCREWS
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE INC; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 9574791
• Report Number: 2031966-2020-00004
• Device Sequence Number: 2901584
• Product Code: NKB
• UDI-Device Identifier: 00887517450678
• UDI-Public: 887517450678
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/03/2020

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: Health Professional
• Device Model Number: 8806555A
• Device Lot Number: NU11183
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1